Effect of Bacillus Subtilis BS50 Supplementation on Gastrointestinal Symptoms in Healthy Adults

Completed · Not applicable · Has a placebo group

Conditions studied: Gastrointestinal Health, Immune Health, Cardiovascular Health, Digestive Health

In brief

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.

Key facts

Study ID

NCT05004454

Run by

BIO-CAT Microbials, LLC

People needed

76

Starts

2021-07-19

Expected to finish

2021-11-08

Last updated by the study team

2023-01-05

Who can join

Age: 30 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Biofortis, Merieux Nutrisciences — Addison, Illinois, United States

Full record on ClinicalTrials.gov

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