The Effects of a Novel Probiotic on Gastrointestinal Health in Generally Healthy Adults

NCT05595980 | Completed DMC

• 1 other identifier: BIO-2210
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to investigate the effect of an oral probiotic (Bacillus sp. spore preparation) on abdominal bloating, flatulence, and burping in generally healthy adults. Secondary outcomes include intestinal barrier integrity and fecal microbiome properties (taxonomical structure, diversity, and function).

Conditions

Gastrointestinal Health; Immune Health; Digestive Health

Keywords

Bacillus; probiotic; bloating; microbiome; metagenomics; inestinal; permeability

Outcome Measures

Primary Outcomes (1)

• Composite score of abdominal bloating, flatulence, and burping (daily GITQ)

  Between placebo and probiotic treatments, the difference in the proportion of participants with a decrease (indicating improvement) in the 7-day total composite score of abdominal bloating, flatulence, and burping, from baseline to week 8, where an increase in scores (indicating worsening) cannot occur within any of the 3 symptoms (daily Gastrointestinal Tolerance Questionnaire \[GITQ\])

  9 weeks

Secondary Outcomes (47)

• Composite score of abdominal bloating, flatulence, and burping (7-day recall GITQ)

  9 weeks

• Composite score of 8 GI symptoms (daily GITQ)

  9 weeks

• Composite score of 8 GI symptoms (7-day recall GITQ)

  9 weeks

• Individual GI symptom scores (daily GITQ)

  9 weeks

• Individual GI symptom scores (7-day recall GITQ)

  9 weeks

Other Outcomes (1)

• Fecal metabolome profile

  Day 57

Study Arms (2)

Probiotic

EXPERIMENTAL

Bacillus strain spore preparation

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo maltodextrin

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Participants will consume 1 capsule containing 2 billion CFU of a Bacillus strain spore preparation once daily for 56 days

Probiotic

Placebo DIETARY_SUPPLEMENT

Participants will consume 1 capsule containing maltodextrin once daily for 56 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 (Day -7)
• BMI of 18.50 to 31.99 kg/m\^2, inclusive, at Visit 1 (Day -7)
• Have ≥ 3 weekly total symptom score obtained by combining ratings for gas/flatulence, abdominal bloating, and burping symptoms (e.g., 3 days with a mild severity across the three symptoms, 1 day of mild severity and 1 day of moderate severity across the three symptoms, or 1 day of severe severity across the three symptoms)
• Consumes a typical American diet (defined as ≤ 3 servings/d of fruits and vegetables combined and \< 3 servings/d of whole grains)
• Non-user of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) with no plans to begin use during the study period
• Non-user or former users (cessation ≥ 12 months) of any marijuana or hemp products and has no plans to use marijuana or hemp products during the study period
• Willing to maintain physical activity and exercise patterns, body weight, and habitual diet throughout the trial
• Willing to limit alcohol consumption to ≤ 2 standard drinks per day throughout the trial
• No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator

You may not qualify if:

• Known sensitivity, intolerability, or allergy to any of the study products or their excipients
• Abnormal laboratory test results of clinical significance at Visit 1 (Day -7), at the discretion of the Clinical Investigator
• Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, gastric reflux, indigestion, dyspepsia, Crohn's disease, celiac disease, history of surgery for weight loss, gastroparesis, and clinically significant lactose or gluten intolerance or other food or ingredient allergies)
• Pre-menopausal female subject with an irregular menstrual cycle (regular cycle defined as 21 to 35 days in length for the last 3 months prior to Visit 1)
• Recent (within 2 weeks of Visit 1; Day -7) history of an episode of acute GI illness such as nausea/vomiting or diarrhea (defined as ≥ 3 loose or liquid stools/d)
• Self-reported history (within 6 weeks of Visit 1; Day -7) of constipation (defined as fewer than three bowel movements per week)
• 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. Conditions which are well-controlled or resolved will be assessed by the Clinical Investigator on a case-by-case basis.
• Uncontrolled hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -7)
• Have received a COVID-19 vaccine within 2 weeks of randomization or expected to receive a COVID-19 vaccine during the study period
• Had a positive SARS-CoV2 test and experienced symptoms for \> 2 months (i.e. "long-haulers")
• Known allergy, intolerances or sensitivity to milk, soy, or wheat
• Extreme dietary habits at the discretion of the Clinical Investigator
• History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer
• Major trauma or any other surgical event within 3 months of Visit 1 (Day -7)
• Signs or symptoms of an active infection of clinical relevance within 5 days of Visit 1 (Day -7)

Sponsors & Collaborators

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

Study Sites (1)

Biofortis Clinical Research, Inc.

Addison, Illinois, 60101, United States

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

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
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 27, 2022
• Study Start: September 19, 2022
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: February 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)