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

Completed · Not applicable · Has a placebo group

Conditions studied: Gastrointestinal Health, Immune Health, Digestive Health

In brief

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).

Key facts

Study ID: NCT05595980
Run by: BIO-CAT Microbials, LLC
People needed: 80
Starts: 2022-09-19
Expected to finish: 2023-02-03
Last updated by the study team: 2023-02-06

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 (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
Willing to refrain from exclusionary medications, supplements, and products throughout the study
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)
Weight loss or gain > 4.5 kg in the 3 months prior to Visit 1 (Day -7)
Currently or planning to be on a weight loss regimen during the study
Antibiotic use within 3 months of Visit 1 (Day -7) and throughout the study period
Use of steroids within 1 month of Visit 1 (Day -7) 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 (Day -7)
Use of medications (over-the-counter or prescription) and/or dietary supplements, known to influence GI function, including but not limited to, pre- and probiotic supplements as well as foods or beverages containing live probiotics (e.g., yogurt, kombucha), fiber supplements, laxatives, enemas, suppositories, H2 blockers, proton pump inhibitors, antacids, anti-diarrheal agents, anti-depressants, and/or anti-spasmodic within 2 weeks of Visit 1 (Day -7) and throughout the study period
Participated in endoscopy or endoscopy preparation within 3 months prior to Visit 1 (Day -7)
Exposure to any non-registered drug product within 4 weeks prior to Visit 1 (Day -7)
Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period
Recent history (within 12 months of screening; Visit 1; Day -7) of alcohol or substance abuse

Where it is running

Biofortis Clinical Research, Inc. — Addison, Illinois, United States

Full record on ClinicalTrials.gov

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