Cardiovascular Health Clinical Trial
Official title:
A Randomized, Parallel, Double-blind, Placebo-Controlled Study to Investigate the Effect of a Bacillus Subtilis BS50 Spore Preparation on Gastrointestinal Symptoms in Healthy Adults
NCT number | NCT05004454 |
Other study ID # | BIO-2112 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 19, 2021 |
Est. completion date | November 8, 2021 |
Verified date | January 2023 |
Source | BIO-CAT Microbials, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to investigate the effect of a novel Bacillus subtilis spore preparation on abdominal bloating, flatulence, and burping in healthy adults.
Status | Completed |
Enrollment | 76 |
Est. completion date | November 8, 2021 |
Est. primary completion date | November 8, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 30 Years to 65 Years |
Eligibility | Inclusion Criteria: - Male or female, 30-65 years of age, inclusive at Visit 1. - BMI of 18.0 to 31.9 kg/m², inclusive, at Visit 1. - Have =3 weekly total symptom score obtained by combining ratings for abdominal bloating, flatulence, and burping from the GITQ. - Consumes a typical American diet. Exclusion Criteria: - Abnormal laboratory test results of clinical significance at Visit 1. - Clinically important GI condition that would potentially interfere with the evaluation of the study product. - Recent (within 2 weeks of Visit 1) history of an episode of acute GI illness such as nausea/vomiting or diarrhea. - Self-reported history (within 6 weeks of Visit 1) of constipation or diarrhea. - Uncontrolled and/or clinically important pulmonary (including uncontrolled asthma), cardiac (including, but not limited to, atherosclerotic disease, history of myocardial infarction, peripheral arterial disease, stroke), hepatic, renal, endocrine (including Type 1 and Type 2 diabetes mellitus), hematologic, immunologic, neurologic (such as Alzheimer's or Parkinson's disease), psychiatric (including depression and/or anxiety disorders) or biliary disorders. - Uncontrolled hypertension as defined by the blood pressure measured at Visit 1. - Have received a COVID vaccine within 2 weeks of Visit 2 or expected to receive a COVID vaccine during the study period. - Had a positive SARS-CoV-2 test and experienced symptoms for >2 months. - History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer. - Weight loss or gain >4.5 kg in the 3 months prior to Visit 1. - Antibiotic use within 3 months of Visit 1 and throughout the study period. - Use of steroids within 1 month of Visit 1 and throughout the study period. - Chronic use (i.e., daily on a regular basis) of anti-inflammatory medications (e.g., NSAIDS) within 1 month of Visit 1. - Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function. |
Country | Name | City | State |
---|---|---|---|
United States | Biofortis, Merieux Nutrisciences | Addison | Illinois |
Lead Sponsor | Collaborator |
---|---|
BIO-CAT Microbials, LLC | Biofortis Clinical Research, Inc. |
United States,
Garvey SM, Mah E, Blonquist TM, Kaden VN, Spears JL. The probiotic Bacillus subtilis BS50 decreases gastrointestinal symptoms in healthy adults: a randomized, double-blind, placebo-controlled trial. Gut Microbes. 2022 Jan-Dec;14(1):2122668. doi: 10.1080/1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abdominal bloating, flatulence, and/or burping | Daily, 8-item Gastrointestinal Tolerance Questionnaire | 6 weeks | |
Secondary | Composite score of GI symptoms | Abdominal bloating, flatulence, burping, nausea, vomiting, abdominal cramping, stomach rumbling, and reflux (Gastrointestinal Tolerance Questionnaire) | 6 weeks | |
Secondary | Individual GI symptoms scores other than abdominal bloating, flatulence, and burping | Nausea, vomiting, abdominal cramping, stomach rumbling, and reflux (Gastrointestinal Tolerance Questionnaire) | 6 weeks | |
Secondary | Bowel function | Stool frequency, stool consistency, straining and discomfort during bowel movement, sensation of incomplete evacuation (Bowel Habits Diary with Bristol Stool Scale) | 6 weeks | |
Secondary | Biomarkers of gut permeability | Blood levels of zonulin, occludin, and lipopolysaccharide binding protein | 6 weeks | |
Secondary | Biomarkers of immune health | Blood levels of C-reactive protein, IL-8, IL-6, IL-10, IFN-?, and TNF-a | 6 weeks | |
Secondary | Blood lipid profiling | Blood levels of triglyceride, total cholesterol (total-C), LDL-C, and HDL-C | 6 weeks | |
Secondary | Incidence and duration of cold/flu/respiratory infection | Weekly Sleep Quality and Respiratory Infection Questionnaire | 6 weeks | |
Secondary | Sleep quality | Weekly Sleep Quality and Respiratory Infection Questionnaire | 6 weeks | |
Secondary | Safety - Adverse Events | Self-reported adverse events at Visits 2 and 3 | 7 weeks | |
Secondary | Safety - Blood Chemistry Profile | Albumin, alkaline phosphatase, total bilirubin, calcium, chloride, creatinine, blood urea nitrogen, potassium, aspartate, aminotransferase, alanine aminotransferase, sodium, total protein, carbon dioxide, osmolality, and glucose | 7 weeks | |
Secondary | Safety - Blood Hematology Profile | White blood cell count, red blood cell count, hemoglobin concentration, hematocrit (as volume percent), mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, neutrophils, lymphocytes, monocytes, eosinophils, basophils, and platelet counts | 7 weeks |
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