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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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The purpose of this study is to investigate the effects of OPTI-BIOMEâ„¢ (Bacillus subtilis MB40), a probiotic supplement, on bloating, gas and abdominal discomfort symptoms in otherwise healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPTI-BIOMEâ„¢ Bacillus subtilis MB40 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPTI-BIOMEâ„¢ Bacillus subtilis MB40 | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly mean of the daily bloating scores | Discomfort, Gas and Bloating questionnaire | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly mean of the daily gas score (flatulence) | Discomfort, Gas and Bloating questionnaire | 4 weeks |
| Weekly mean of the abdominal pain score | Discomfort, Gas and Bloating questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically significant abnormal vital signs | 4 weeks | |
| Incidence of clinically significant abnormal complete blood panel | 4 weeks | |
| Incidence of clinically significant abnormal electrolytes |
Inclusion Criteria:
Male or female 18-75 years (inclusive) of age
BMI 18.5-29.9 ±1 kg/m2
Abdominal bloating intensity score ≥5 and at least two days of bloating over the 2 weeks prior to screening (assessed at screening by Abdominal Bloating questionnaire)
Participants categorized as 'high bloaters' as defined by an average bloating score ≥ 5 during the run-in period assessed at baseline by question 3 of the Modified Daily Abdominal Discomfort, Gas, and Bloating Questionnaire, AND/OR, participants categorized as 'high frequency bloaters' as defined by greater than 7 days of high bloating (defined above) during the run-in period.
If female, participant is not of child bearing potential, which is defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation) OR
Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
Healthy as determined by laboratory results, medical history, and physical exam
Agrees to abstain from consuming unpasteurized bacteria-fermented foods including cheese and yogurt for 1 week prior to screening visit and throughout the study
Agrees to abstain from using fiber supplements 2 weeks prior to screening and for the duration of the study
Agrees to maintain current dietary habits and activity/training levels for two weeks prior to baseline and for the course of the study
Agrees to avoid probiotics for one week prior to screening and for the course of the study
Willingness to complete all the study requirements and attend all clinic visits.
Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tetyana Pelipyagina, MD' | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Clinical Trials Center | Foothill Ranch | California | 92610 | United States | ||
| KGK Clinical Trials Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31719214 | Derived | Penet C, Kramer R, Little R, Spears JL, Parker J, Iyer JK, Guthrie N, Evans M. A Randomized, Double-blind, Placebo-controlled, Parallel Study Evaluating the Efficacy of Bacillus subtilis MB40 to Reduce Abdominal Discomfort, Gas, and Bloating. Altern Ther Health Med. 2021 Jun;27(S1):146-157. |
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| ID | Term |
|---|---|
| D009085 | Mucopolysaccharidosis IV |
| ID | Term |
|---|---|
| D009083 | Mucopolysaccharidoses |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
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| Other |
|
| 4 weeks |
| Modified Gastrointestinal Symptom Rating Scale (GSRS) score | 4 weeks |
| Weekly mean stool consistency scores | Bristol stool scale | 4 weeks |
| Weekly mean number of bowel movements | Daily Bowel Habits Diary | 4 weeks |
| Quality of Life | Rand SF-36 | 4 weeks |
| 4 weeks |
| Incidence of clinically significant abnormal kidney function panel | 4 weeks |
| Incidence of clinically significant abnormal liver function panel | 4 weeks |
| Incidence of adverse events | 4 weeks |
| Orlando |
| Florida |
| 32806 |
| United States |
| KGK Synergize Inc. | London | Ontario | N6A5R8 | Canada |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D016464 | Lysosomal Storage Diseases |
| D017520 | Mucinoses |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |