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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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Overweight has become a critical issue in North America and the market value of weight loss products is expected to rise as the population becomes more health-conscious and aware of the risks associated with excess body weight. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.
In early adulthood, excess body weight is a risk factor associated with several health complications later on in life and probiotics have been used for decades for maintaining intestinal health, and in recent years probiotics have been proposed for weight management. This randomized, placebo-controlled, clinical trial investigates the effect of Bifidobacterium breve supplementation with exercise intervention on fat loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo delivered in capsule format. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. |
|
| B. breve | Experimental | Capsule containing B breve strain. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B. breve strain | Dietary Supplement | Probiotic capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fat Loss (g) | The difference in change in fat loss from baseline (g), as assessed by Dual-Energy X-Ray Absorptiometry (DXA), between B. breve and placebo after 12 weeks of supplementation. Body tissue density will be measured by a form of X-ray radiation and converted into body fat and muscle mass percentage for assessment | 12 weeks from baseline |
| Change in Fat Loss (Percentage of Body Weight) | The difference in change in fat loss from baseline (percentage of body weight), as assessed by Dual-Energy X-Ray Absorptiometry (DXA), between B. breve and placebo after 12 weeks of supplementation. Body tissue density will be measured by a form of X-ray radiation and converted into body fat and muscle mass percentage for assessment | 12 weeks from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | The difference in change from baseline between B. breve and placebo in body weight after 12 weeks of supplementation | 12 weeks from baseline |
| BMI | The difference in change from baseline between B. breve and placebo in BMI after 12 weeks of supplementation |
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Inclusion Criteria:
Male or female between 20 and 65 years of age, inclusive
BMI from 25.0 to 29.9 kg/m2, inclusive
Female participants are not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening
Or, Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
Self-reported stable body weight for the past 3 months defined as not having gained or lost more than 5 kg of body weight throughout the 3 months prior to baseline
Participants with the following body fat percentages as determined by Bioelectrical Impedance Analysis (BIA):
Agrees to follow the diet and exercise guidelines for the duration of the study
Willingness to complete questionnaires, records, and diaries associated with the study, to complete all clinic visits, and provide stool samples
Provide voluntary, written, informed consent to participate in the study
Healthy as determined by medical history, laboratory results and physical exam as assessed by the Qualified Investigator (QI)
Exclusion Criteria
Women who are pregnant, breastfeeding or planning to become pregnant during the trial
Allergy, sensitivity, or intolerance to the investigational product's active or inactive ingredients
Clinically significant abnormal laboratory results at screening as assessed by the QI
Current or history of any significant gastrointestinal disease requiring medication (e.g. GERD, gastroenteritis)
Irregular sleep schedule
Chronic diarrhea or constipation
Participants with hypertension and are on antihypertensive medication
Type I or Type II diabetes
Participants with hyperlipidemia and are on medication
Self-reported sleep apnea
Self-reported current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
Unstable metabolic disease or chronic diseases as assessed by the QI
History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom-free for 6 months
Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case by case basis
Major surgery in the past 3 months or individuals who have planned surgery during the trial period. Participants with minor surgery will be considered on a case-by-case basis by the QI
Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
Individuals with an autoimmune disease or are immune-compromised
Self-reported HIV-, Hepatitis B- and/or C-positive diagnosis
Blood/bleeding disorders as determined by laboratory results
Self-reported mental or neuropsychological condition and/or cognitive impairment that, in the QI's opinion, could interfere with study participation
Metal implants that may affect the DXA scan results will be assessed on a case- by-case basis by the QI.
Current use of prescribed medications listed in Section Prescribed Medications as follows:
Current use of over-the-counter medications, supplements, foods and/or drinks as follows:
Use of cannabinoid products within 60 days of baseline. History of cannabis used will be assessed on a case by case basis by the QI
Use of tobacco products within 60 days of baseline
Self-reported alcohol or drug abuse within the last 12 months
High alcohol intake (average of > 2 standard drinks per day or > 10 per week)
Current employment that calls for shift work or have worked shift work in the last 3 weeks
Participation in other clinical research trials 30 days prior to screening
Blood donation 30 days prior to screening, during the study, or a planned donation within 30-days of the last study visit
Individuals who are unable to give informed consent
Any other condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures, or which may pose a significant risk to the participant
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| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc | London | Ontario | N6A 5RB | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | B. Breve | Capsule containing B breve strain. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. B. breve strain: Probiotic capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. |
| FG001 | Placebo | Placebo delivered in capsule format. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. Placebo: Placebo capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
for the ITT population
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| ID | Title | Description |
|---|---|---|
| BG000 | B. Breve | Capsule containing B breve strain. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. B. breve strain: Probiotic capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Fat Loss (g) | The difference in change in fat loss from baseline (g), as assessed by Dual-Energy X-Ray Absorptiometry (DXA), between B. breve and placebo after 12 weeks of supplementation. Body tissue density will be measured by a form of X-ray radiation and converted into body fat and muscle mass percentage for assessment | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | g | 12 weeks from baseline |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | B. Breve | Capsule containing B breve strain. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. B. breve strain: Probiotic capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of B. breve strain in the morning before breakfast for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment | Upset stomach, Nausea, Diarrhea, Vomiting, Constipation, Greenish stool, Heartburn, Indigestion, Ineffective straining at stool, Gastric pain |
none applicable
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Morinaga Milk Industry Co., Ltd. | +81-46-252-3067 | izen-ri138@morinagamilk.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 26, 2023 | Oct 1, 2025 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2023 | Oct 1, 2025 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Placebo | Dietary Supplement | Placebo capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. |
|
| 12 weeks from baseline |
| Android/Gynoid Fat Ratio | The difference in change from baseline between B. breve and placebo in android/gynoid fat ratio as assessed by DXA after 12 weeks of supplementation. Android-gynoid percent fat ratio is a pattern of body fat distribution that is associated with an increased risk for metabolic syndrome in healthy adults. The measurement of android/gynoid fat ratio is defined as the ratio of the percentage of android fat to the percentage of gynoid fat. | 12 weeks from baseline |
| Muscle Mass (g) | The difference in change from baseline between B. breve and placebo in muscle mass (g) as assessed by DXA after 12 weeks of supplementation. | 12 weeks from baseline |
| Muscle Mass (Percentage of Body Weight) | The difference in change from baseline between B. breve and placebo in muscle mass (percentage of body weight) as assessed by DXA after 12 weeks of supplementation. | 12 weeks from baseline |
| Waist Circumference | The difference in change from baseline between B. breve and placebo in Waist circumference after 6 and 12 weeks of supplementation. | Baseline, 6 weeks and 12 weeks |
| Hip Circumference | The difference in change from baseline between B. breve and placebo in hip circumference after 6 and 12 weeks of supplementation. | Baseline, 6 weeks and 12 weeks |
| Waist/Hip Circumference Ratio | The difference in change from baseline between B. breve and placebo in waist/hip circumference ratio after 6 and 12 weeks of supplementation. The waist/hip circumference ratio is defined as the percentage of waist circumference to hip circumference. The change in waist/hip circumference ratio from baseline to week 12 was calculated. | Baseline, 6 weeks and 12 weeks |
| Microbiota Analysis: Shannon Index | Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity. The Shannon Index (or Shannon-Wiener/Shannon-Weaver index) is a widely used metric in ecology to quantify alpha diversity, which measures both species richness and evenness. The value of the Shannon Index ranges from a minimum of zero, when there is only one species present (no diversity), to a maximum of ln(S), the natural logarithm of the total number of species (richness) to the base of Euler's number (e), which means all species are equally abundant. High values indicate a diverse, balanced community. | 12 weeks from baseline |
| Microbiota Analysis: Chao1 Index | Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity. The Chao1 Index estimates total species richness, including rare/undetected species. The value of the Chao1 Index ranges from a minimum, close to zero (suggesting reduced richness, often observed in dysbiosis) to a theoretically unbounded maximum, as it depends on rare species. Higher values indicate greater estimated species richness, generally associated with a healthier gut microbiome, linked to resilience, metabolic versatility, and protection against pathogens. | 12 weeks from baseline |
| Microbiota Analysis: Evenness Index | Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity. The Evenness Index measures how evenly individuals are distributed among species in a community, such as the gut microbiome. It complements species richness (the number of species) to describe diversity, ranging from 0 (only a single species, meaning there is no evenness.) to 1, where 1 indicates perfect evenness, meaning all species are equally abundant. Higher Evenness Index value (closer to 1) is generally considered better, as it suggests a more balanced and stable ecosystem. Conversely, lower value (closer to 0) is generally considered worse, as it suggests that a few species dominate the community, which can be associated with dysbiosis or an unhealthy gut microbiome. | 12 weeks from baseline |
| Microbiota Analysis: Observed ASV Index | Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity. Observed ASV (Amplicon Sequence Variants) Index refers to the number of distinct Amplicon Sequence Variants (ASVs) detected in a sample. ASVs are highly resolved sequences used to identify and differentiate microbial taxa, providing finer resolution than traditional Operational Taxonomic Units (OTUs). The range of Observed ASV Index in gut microbiome samples can range from a few hundred to several thousand, depending on several factors, including sample source, health status of the host, diet and lifestyle, as well as sequencing depth and methodology. Typically, higher Observed ASV Index indicates a more diverse microbial community, which can contribute to improved gut function and overall health. | 12 weeks from baseline |
| Microbiota Analysis: Faith's PD Index | Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity. Faith's Phylogenetic Diversity (PD) is a measure used in ecology to quantify the biodiversity of a sample based on the phylogenetic tree. In the context of the gut microbiome, it specifically measures the diversity of microbial species by considering both the number of species present (richness) and the phylogenetic differences between them. In practice, the values can range from very low (close to zero, indicating low microbial diversity linked to various health issues) to very high (indicates greater evolutionary diversity, which may enhance ecosystem resilience and is generally considered better in the context of gut microbiome health.). | 12 weeks from baseline |
| Change in Weight in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in weight in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Body Mass Index in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in body mass index in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Total Body Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in total body fat (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Total Body Fat (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in total body fat (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Muscle Mass (g) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in muscle mass (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Muscle Mass (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in muscle mass (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Android Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in android fat (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Android Fat (% of Android Tissue) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in android fat (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Gynoid Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in gynoid fat (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Gynoid Fat (% of Gynoid Tissue) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in gynoid fat (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Android:Gynoid Fat Ratio in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in android:gynoid fat ratio in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Waist Circumference in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in waist circumference in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Hip Circumference in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in hip circumference, in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Change in Waist:Hip Circumference Ratio in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in waist:hip circumference ratio in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | 12 weeks from baseline |
| Total Cholesterol | The difference in change from baseline between B. breve and placebo in total cholesterol after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| HDL-cholesterol | The difference in change from baseline between B. breve and placebo in HDL-cholesterol after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| LDL-cholesterol | The difference in change from baseline between B. breve and placebo in LDL-cholesterol after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| Triglycerides | The difference in change from baseline between B. breve and placebo in triglycerides after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| Fasting Blood Glucose | The difference in change from baseline between B. breve and placebo in fasting blood glucose after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| HbA1c | The difference in change from baseline between B. breve and placebo in HbA1c after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| Fasting Insulin | The difference in change from baseline between B. breve and placebo in fasting insulin after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| Alkaline Phosphatase (ALP) | The difference in change from baseline between B. breve and placebo in ALP after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| Gamma-glutamyl Transferase (GGT) | The difference in change from baseline between B. breve and placebo in GGT after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| Alanine Aminotransferase (ALT) | The difference in change from baseline between B. breve and placebo in ALT after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| Aspartate Transaminase (AST) | The difference in change from baseline between B. breve and placebo in AST after 12 weeks of supplementation. | Baseline and 12 weeks of supplementation |
| Frequency of Bowel Movements | The difference in change from baseline between B. breve and placebo in Frequency of bowel movements after 6 and 12 weeks of supplementation. | Baseline, 6 and 12 weeks of supplementation |
| BG001 | Placebo | Placebo delivered in capsule format. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. Placebo: Placebo capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Fat mass | Mean | Standard Deviation | g |
|
| Fat mass ratio | Mean | Standard Deviation | percentage of body weight |
|
| OG001 | Placebo | Placebo delivered in capsule format. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. Placebo: Placebo capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. |
|
|
| Primary | Change in Fat Loss (Percentage of Body Weight) | The difference in change in fat loss from baseline (percentage of body weight), as assessed by Dual-Energy X-Ray Absorptiometry (DXA), between B. breve and placebo after 12 weeks of supplementation. Body tissue density will be measured by a form of X-ray radiation and converted into body fat and muscle mass percentage for assessment | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of body weight | 12 weeks from baseline |
|
|
|
| Secondary | Body Weight | The difference in change from baseline between B. breve and placebo in body weight after 12 weeks of supplementation | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | kg | 12 weeks from baseline |
|
|
|
| Secondary | BMI | The difference in change from baseline between B. breve and placebo in BMI after 12 weeks of supplementation | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | kilogram per square meter (kg/m^2) | 12 weeks from baseline |
|
|
|
| Secondary | Android/Gynoid Fat Ratio | The difference in change from baseline between B. breve and placebo in android/gynoid fat ratio as assessed by DXA after 12 weeks of supplementation. Android-gynoid percent fat ratio is a pattern of body fat distribution that is associated with an increased risk for metabolic syndrome in healthy adults. The measurement of android/gynoid fat ratio is defined as the ratio of the percentage of android fat to the percentage of gynoid fat. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of gynoid fat ratio | 12 weeks from baseline |
|
|
|
| Secondary | Muscle Mass (g) | The difference in change from baseline between B. breve and placebo in muscle mass (g) as assessed by DXA after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | g | 12 weeks from baseline |
|
|
|
| Secondary | Muscle Mass (Percentage of Body Weight) | The difference in change from baseline between B. breve and placebo in muscle mass (percentage of body weight) as assessed by DXA after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of body weight | 12 weeks from baseline |
|
|
|
| Secondary | Waist Circumference | The difference in change from baseline between B. breve and placebo in Waist circumference after 6 and 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | cm | Baseline, 6 weeks and 12 weeks |
|
|
|
| Secondary | Hip Circumference | The difference in change from baseline between B. breve and placebo in hip circumference after 6 and 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | cm | Baseline, 6 weeks and 12 weeks |
|
|
|
| Secondary | Waist/Hip Circumference Ratio | The difference in change from baseline between B. breve and placebo in waist/hip circumference ratio after 6 and 12 weeks of supplementation. The waist/hip circumference ratio is defined as the percentage of waist circumference to hip circumference. The change in waist/hip circumference ratio from baseline to week 12 was calculated. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of hip circumference | Baseline, 6 weeks and 12 weeks |
|
|
|
| Secondary | Microbiota Analysis: Shannon Index | Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity. The Shannon Index (or Shannon-Wiener/Shannon-Weaver index) is a widely used metric in ecology to quantify alpha diversity, which measures both species richness and evenness. The value of the Shannon Index ranges from a minimum of zero, when there is only one species present (no diversity), to a maximum of ln(S), the natural logarithm of the total number of species (richness) to the base of Euler's number (e), which means all species are equally abundant. High values indicate a diverse, balanced community. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | Shannon Index | 12 weeks from baseline |
|
|
|
| Secondary | Microbiota Analysis: Chao1 Index | Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity. The Chao1 Index estimates total species richness, including rare/undetected species. The value of the Chao1 Index ranges from a minimum, close to zero (suggesting reduced richness, often observed in dysbiosis) to a theoretically unbounded maximum, as it depends on rare species. Higher values indicate greater estimated species richness, generally associated with a healthier gut microbiome, linked to resilience, metabolic versatility, and protection against pathogens. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | Chao1 index | 12 weeks from baseline |
|
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| Secondary | Microbiota Analysis: Evenness Index | Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity. The Evenness Index measures how evenly individuals are distributed among species in a community, such as the gut microbiome. It complements species richness (the number of species) to describe diversity, ranging from 0 (only a single species, meaning there is no evenness.) to 1, where 1 indicates perfect evenness, meaning all species are equally abundant. Higher Evenness Index value (closer to 1) is generally considered better, as it suggests a more balanced and stable ecosystem. Conversely, lower value (closer to 0) is generally considered worse, as it suggests that a few species dominate the community, which can be associated with dysbiosis or an unhealthy gut microbiome. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | Evenness Index | 12 weeks from baseline |
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| Secondary | Microbiota Analysis: Observed ASV Index | Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity. Observed ASV (Amplicon Sequence Variants) Index refers to the number of distinct Amplicon Sequence Variants (ASVs) detected in a sample. ASVs are highly resolved sequences used to identify and differentiate microbial taxa, providing finer resolution than traditional Operational Taxonomic Units (OTUs). The range of Observed ASV Index in gut microbiome samples can range from a few hundred to several thousand, depending on several factors, including sample source, health status of the host, diet and lifestyle, as well as sequencing depth and methodology. Typically, higher Observed ASV Index indicates a more diverse microbial community, which can contribute to improved gut function and overall health. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | Observed ASV Index | 12 weeks from baseline |
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| Secondary | Microbiota Analysis: Faith's PD Index | Alpha diversity at baseline and after 12-week intake were calculated by R. Alpha diversity index is usually unitless since it is a numerical value calculated by a mathematical formula, not a physical quantity. Faith's Phylogenetic Diversity (PD) is a measure used in ecology to quantify the biodiversity of a sample based on the phylogenetic tree. In the context of the gut microbiome, it specifically measures the diversity of microbial species by considering both the number of species present (richness) and the phylogenetic differences between them. In practice, the values can range from very low (close to zero, indicating low microbial diversity linked to various health issues) to very high (indicates greater evolutionary diversity, which may enhance ecosystem resilience and is generally considered better in the context of gut microbiome health.). | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | Faith's PD Index | 12 weeks from baseline |
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| Secondary | Change in Weight in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in weight in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | kg | 12 weeks from baseline |
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| Secondary | Change in Body Mass Index in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in body mass index in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | kilogram per square meter (kg/m^2) | 12 weeks from baseline |
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| Secondary | Change in Total Body Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in total body fat (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | g | 12 weeks from baseline |
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| Secondary | Change in Total Body Fat (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in total body fat (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of body weight | 12 weeks from baseline |
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| Secondary | Change in Muscle Mass (g) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in muscle mass (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | g | 12 weeks from baseline |
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| Secondary | Change in Muscle Mass (% of Body Weight) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in muscle mass (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of body weight | 12 weeks from baseline |
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| Secondary | Change in Android Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in android fat (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | g | 12 weeks from baseline |
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| Secondary | Change in Android Fat (% of Android Tissue) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in android fat (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of android tissue | 12 weeks from baseline |
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| Secondary | Change in Gynoid Fat (g) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in gynoid fat (g) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | g | 12 weeks from baseline |
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| Secondary | Change in Gynoid Fat (% of Gynoid Tissue) in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in gynoid fat (%) in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of gynoid tissue | 12 weeks from baseline |
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| Secondary | Change in Android:Gynoid Fat Ratio in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in android:gynoid fat ratio in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of gynoid fat | 12 weeks from baseline |
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| Secondary | Change in Waist Circumference in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in waist circumference in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | cm | 12 weeks from baseline |
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| Secondary | Change in Hip Circumference in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in hip circumference, in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | cm | 12 weeks from baseline |
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| Secondary | Change in Waist:Hip Circumference Ratio in Participant Groups Classified by Microbiota Composition at Week 0 | The change from baseline between B. breve and placebo in waist:hip circumference ratio in participant groups classified by microbiota composition at week 0, after 12 weeks of supplementation. These individual outcomes comprise relevant aspects of body composition. Each outcome will be analyzed separately and interpreted separately as well as collectively to inform relevant changes to body composition as a whole during the study. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of hip circumference | 12 weeks from baseline |
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| Secondary | Total Cholesterol | The difference in change from baseline between B. breve and placebo in total cholesterol after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 weeks of supplementation |
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| Secondary | HDL-cholesterol | The difference in change from baseline between B. breve and placebo in HDL-cholesterol after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 weeks of supplementation |
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| Secondary | LDL-cholesterol | The difference in change from baseline between B. breve and placebo in LDL-cholesterol after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 weeks of supplementation |
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| Secondary | Triglycerides | The difference in change from baseline between B. breve and placebo in triglycerides after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 weeks of supplementation |
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| Secondary | Fasting Blood Glucose | The difference in change from baseline between B. breve and placebo in fasting blood glucose after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | mmol/L | Baseline and 12 weeks of supplementation |
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| Secondary | HbA1c | The difference in change from baseline between B. breve and placebo in HbA1c after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | Baseline and 12 weeks of supplementation |
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| Secondary | Fasting Insulin | The difference in change from baseline between B. breve and placebo in fasting insulin after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | pmol/L | Baseline and 12 weeks of supplementation |
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| Secondary | Alkaline Phosphatase (ALP) | The difference in change from baseline between B. breve and placebo in ALP after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | U/L | Baseline and 12 weeks of supplementation |
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| Secondary | Gamma-glutamyl Transferase (GGT) | The difference in change from baseline between B. breve and placebo in GGT after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | U/L | Baseline and 12 weeks of supplementation |
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| Secondary | Alanine Aminotransferase (ALT) | The difference in change from baseline between B. breve and placebo in ALT after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | U/L | Baseline and 12 weeks of supplementation |
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| Secondary | Aspartate Transaminase (AST) | The difference in change from baseline between B. breve and placebo in AST after 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | U/L | Baseline and 12 weeks of supplementation |
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| Secondary | Frequency of Bowel Movements | The difference in change from baseline between B. breve and placebo in Frequency of bowel movements after 6 and 12 weeks of supplementation. | Per-protocol population after excluding the participants with concomitant medication or foods according to the judgement of principal investigator. | Posted | Mean | Standard Deviation | bowel movements | Baseline, 6 and 12 weeks of supplementation |
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| 0 |
| 48 |
| 0 |
| 48 |
| 36 |
| 48 |
| EG001 | Placebo | Placebo delivered in capsule format. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. Placebo: Placebo capsule. Participants will be instructed to take 2 capsules of placebo for 4 weeks during the run-in period. On day 1 participants will be instructed to take 2 capsules of placebo in the morning before breakfast for 12 weeks. | 0 | 47 | 0 | 47 | 32 | 47 |
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| Eye inflammation | Eye disorders | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | Non-systematic Assessment |
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| Blood and urine biochemical indicator abnormal | Investigations | Non-systematic Assessment | Urinalysis abnormal NOS Alanine aminotransferase increased Urinalysis abnormal NOS Bilirubin total increased Urinalysis abnormal NOS Elevated K |
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| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Backache Muscle pain Pain in toe Plantar fasciitis Aching pain in hands, forearms, elbows Tenderness muscle Pain in hip |
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| Arthropod sting, Head injury | Injury, poisoning and procedural complications | Non-systematic Assessment | Bee sting Head injury |
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| Pain, Fatigue, Pyrexia | General disorders | Non-systematic Assessment | Shooting pain Tiredness Chills & fever General body pain |
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| Melanocytic naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Mole changes |
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| Headache | Nervous system disorders | Non-systematic Assessment | Headache Difficulty sleeping Sinus headache Tension headache |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | Non-systematic Assessment | Dysuria |
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| Dysmenorrhea, Vulvovaginal discomfort | Reproductive system and breast disorders | Non-systematic Assessment |
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| Oropharyngeal pain, Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Nose bleed Sore throat |
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| Onychalgia, Nail discoloration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Allergy to arthropod sting | Immune system disorders | Non-systematic Assessment |
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Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |