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

NCT05004454 | Completed DMC

• 1 other identifier: BIO-2112
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Health; Immune Health; Cardiovascular Health; Digestive Health

Keywords

probiotic; Bacillus; subtilis; bloating

Outcome Measures

Primary Outcomes (1)

• Abdominal bloating, flatulence, and/or burping

  Daily, 8-item Gastrointestinal Tolerance Questionnaire

  6 weeks

Secondary Outcomes (11)

• Composite score of GI symptoms

  6 weeks

• Individual GI symptoms scores other than abdominal bloating, flatulence, and burping

  6 weeks

• Bowel function

  6 weeks

• Biomarkers of gut permeability

  6 weeks

• Biomarkers of immune health

  6 weeks

Study Arms (2)

Bacillus subtilis BS50

EXPERIMENTAL

Subjects will consume 1 capsule containing 2x10⁹ CFU of a Bacillus subtilis BS50 spore preparation once daily for 42 days.

Dietary Supplement: Bacillus subtilis BS50 spore preparation

Placebo

PLACEBO COMPARATOR

Subjects will consume 1 capsule containing maltodextrin once daily for 42 days.

Dietary Supplement: Maltodextrin

Interventions

Bacillus subtilis BS50 spore preparation DIETARY_SUPPLEMENT

Subjects will consume 1 capsule containing 2x10⁹ CFU of a Bacillus subtilis BS50 spore preparation once daily for 42 days.

Bacillus subtilis BS50

Maltodextrin DIETARY_SUPPLEMENT

Subjects will consume 1 capsule containing maltodextrin once daily for 42 days.

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• BIO-CAT Microbials, LLC: lead
• Biofortis Clinical Research, Inc.: collaborator

Study Sites (1)

Biofortis, Merieux Nutrisciences

Addison, Illinois, 60101, United States

Location

Related Publications (1)

• 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: 10.1080/19490976.2022.2122668.

  PMID: 36269141 RESULT

MeSH Terms

Interventions

maltodextrin

Study Officials

• Dawn Beckman, MD

  Biofortis Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Bacillus subtilis BS50 and placebo powders will be manufactured in to capsules and provided to the clinic in blindly coded containers. The code was generated by parties not responsible for data collection, analysis, or interpretation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 13, 2021
• Study Start: July 19, 2021
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)