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| Name | Class |
|---|---|
| Nutrasource Pharmaceutical and Nutraceutical Services, Inc. | NETWORK |
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This study aims to evaluate the impact of a specific oral probiotic blend on the quality of life of adults with respiratory conditions.
An imbalance and reduction of microbial diversity in the lung microbiota may negatively impact an individual's general health and quality of life. Further, individuals with respiratory conditions may take medications that may alter gut microbiome, which can have a negative impact on outcomes and quality of life. Evidence has emerged that there are interactions between gut and lung microbiomes, demonstrating the opportunity of using oral probiotics to support a healthy gut and/or lung microbiome, and subsequently, the general health and quality of life in this population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 1 capsule of 15 Billion CFU proprietary probiotic blend with 120 mg herbal extracts, taken twice daily. |
|
| Placebo | Placebo Comparator | 1 capsule of placebo, taken twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Active ingredients: Lactobacillus plantarum RSB11, 5 Billion colony forming units (CFU) Lactobacillus acidophilus RSB12, 5 Billion CFU Lactobacillus rhamnosus RSB13, 5 Billion CFU Holy basil leaf extract, 42.0 mg Turmeric root extract, 30.0 mg Vasaka leaf extract, 48.0 mg Inactive ingredients: Microcrystalline Cellulose, Vegan Capsule (Hypromellose), Magnesium Stearate, Silicon Dioxide |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of resB® Lung Support on quality of life | Change from baseline in St. George's Respiratory Questionnaire. The total score summarizes the impact of the condition on overall health status where 100 indicates the worst possible health status and 0 indicates best possible health status | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of resB® Lung Support on lung microbiome | Change from baseline in gut microbiome as assessed by 16S rRNA analysis from sputum samples | 12 weeks |
| To determine the effect of resB® Lung Support on gut microbiome |
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Inclusion Criteria:
Adult participants who are 18-80 years of age (inclusive).
Have been diagnosed with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis and have been on a stable treatment regimen for ≥ 6 months at screening.
Have a body mass index between 18.0-34.9 kg/m2 (inclusive).
Have normal or acceptable to the investigator vital signs (blood pressure, respiratory rate, heart rate) and normal or acceptable to the investigator physical exam findings (if applicable) at screening.
Individuals of childbearing potential must agree to practice a medically acceptable form of birth control for a certain time frame prior to the first dose of study product and throughout the study, including:
Agree to refrain from treatments listed in the protocol in the defined timeframe.
Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Bier, MD | Nutrasource Pharmaceutical and Nutraceutical Services | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coral Research Clinic Corp. | Miami | Florida | 33186 | United States | ||
| Premier Medical Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41254308 | Derived | Nicola T, Wenger NM, Seidman K, Evans M, Yang Y, Chen D, Van Der Pol WJ, Walia A, Lefkowitz EJ, Wang J, LeMoire A, Lin L, Morrow C, Ambalavanan N, Gaggar A, Lal CV. Double-Blind Randomized Placebo-Controlled Trial of a Lactobacillus Probiotic Blend in Chronic Obstructive Pulmonary Disease. Pulm Ther. 2026 Mar;12(1):251-263. doi: 10.1007/s41030-025-00333-y. Epub 2025 Nov 18. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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Randomization at 1:1 ratio for active or placebo
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Double blind
|
|
| Placebo | Other | Active ingredients: N/A Inactive ingredients: Microcrystalline Cellulose, Vegan Capsule (Hypromellose), Magnesium Stearate, Silicon Dioxide |
|
Change from baseline in gut microbiome as assessed by 16S rRNA analysis from fecal samples
| 12 weeks |
| To determine the effect of resB® Lung Support on serum short-chain fatty acids | Change from baseline in serum short-chain fatty acids | 12 weeks |
| To determine the effect of resB® Lung Support on stool short-chain fatty acids | Change from baseline in stool | 12 weeks |
| To determine the effect of resB® Lung Support on biomarkers of inflammation | Change from baseline in serum concentration of metalloproteinase 9 | 12 weeks |
| To determine the effect of resB® Lung Support on biomarkers of inflammation | Change from baseline in serum concentration of tripeptide N-acetyl proline-glycine-proline | 12 weeks |
| To determine the effect of resB® Lung Support on biomarkers of inflammation | Change from baseline in serum concentration of high-sensitivity C-reactive protein | 12 weeks |
| To determine the effect of resB® Lung Support on biomarkers of inflammation | Change from baseline in serum concentration of pro-inflammatory cytokines | 12 weeks |
| To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis | Heart rate measurement | 12 weeks |
| To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis | Blood pressure measurement | 12 weeks |
| To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis | Respiratory rate measurement | 12 weeks |
| To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis | Weight measurement | 12 weeks |
| To assess the safety and tolerability of resB® Lung Support in adult participants with chronic obstructive pulmonary disease or non-cystic fibrosis bronchiectasis | Body mass index measurement | 12 weeks |
| Change in Hemoglobin levels after taking resB® Lung Support | Change in Hemoglobin levels after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resB® Lung Support | Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Albumin after taking resB® Lung Support | Change in Albumin after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Total Protein after taking resB® Lung Support | Change in Total Protein after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Globulin after taking resB® Lung Support | Change in Globulin after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Reb Blood Cell (RBC) count after taking resB® Lung Support | Change in Reb Blood Cell (RBC) count after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in in Red Cell Distribution Width (RDW) after taking resB® Lung Support | Change in in Red Cell Distribution Width (RDW) after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) after taking resB® Lung Support | Change in Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV) after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Mean Corpuscular Hemoglobin (MCH) after taking resB® Lung Support | Change in Mean Corpuscular Hemoglobin (MCH) after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Platelet count after taking resB® Lung Support | Change in Platelet count after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in White Blood Cell (WBC) count after taking resB® Lung Support | Change in White Blood Cell (WBC) count after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in White Blood Cell (WBC) differential after taking resB® Lung Support | Change in White Blood Cell (WBC) differential after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Urea after taking resB® Lung Support | Change in Urea after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Sodium after taking resB® Lung Support | Change in Sodium after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Potassium after taking resB® Lung Support | Change in Potassium after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Chloride after taking resB® Lung Support | Change in Chloride after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Creatinine after taking resB® Lung Support | Change in Creatinine after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Bilirubin-total after taking resB® Lung Support | Change in Bilirubin-total after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Alkaline Phosphatase after taking resB® Lung Support | Change in Alkaline Phosphatase after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Aspartate Aminotransferase (AST) after taking resB® Lung Support | Change in Aspartate Aminotransferase (AST) after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Alanine Aminotransferase (ALT) after taking resB® Lung Support | Change in Alanine Aminotransferase (ALT) after taking resB® Lung Support compared to baseline | 12 weeks |
| Change in Estimated Glomerular Filtration Rate (eGFR) after taking resB® Lung Support | Change in Estimated Glomerular Filtration Rate (eGFR) after taking resB® Lung Support compared to baseline | 12 weeks |
| Safety- participants experiencing adverse events | The number of participants experiencing Treatment Emergent Adverse Events (TEAEs) | 12 weeks |
| Safety- adverse events | The total number Treatment Emergent Adverse Events (TEAEs) | 12 weeks |
| The Villages |
| Florida |
| 32162 |
| United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |