Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health (NCT06397482) | Clinical Trial Compass
CompletedNot Applicable
Effects of an Encapsulated Calcium Butyrate Dietary Supplement on Gut Health
United States20 participantsStarted 2023-10-23
Plain-language summary
The primary objective of this single-arm pilot study is to investigate the effects of an encapsulated calcium butyrate dietary supplement on gastrointestinal (GI) health outcomes in healthy adults, including GI symptom severity (e.g., gas/flatulence and abdominal bloating), bowel habits (frequency and consistency), digestion-associated quality of life, and measures of GI permeability.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥18 to ≤60 years of age at visit 1.
. BMI ≥18.0 and \<32.0 kg/m2 at visit 1.
. A mean ≥3 (at least mild symptoms) in the indigestion domain from the Gastrointestinal Symptom Rating Scale (GSRS) at both visits 1 (day -8) and 2 (day 0).
. Habitually consumes a standard American diet as defined by a Diet ID diet quality score of ≤6 (\~60 on the Healthy Eating Index \[HEI\]-2015).
. Willing to abstain from alcohol consumption and vigorous exercise for 24 hours prior to and following visits 2 (day 0) and 4 (day 43).
. Non-user or former user (daily use; cessation ≥12 months) of tobacco or nicotine products (e.g., cigarette smoking, vaping, chewing tobacco) within 12 months of visit 1, and has no plans to begin use during the study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Indigestion Symptom Severity
Timeframe: Change from baseline (day 0) to end of each week (day 8, 15, 22, 29, 36, and 43)
. Non-user or former user (daily use; cessation ≥12 months) of any marijuana or hemp products within 12 months of visit 1 and has no plans to use marijuana or hemp products during the study period.
. Willing to maintain habitual physical activity level throughout the duration of the study with the exception of the 24 h before and after visits 2 and 4 (days 0 and 43).
Exclusion criteria
. 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 -8), at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to visit 2 (day 0), for subjects with abnormal laboratory test results.
. Clinically important GI condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, 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 subjects 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 -8) 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 -8) 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 that 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 -8; section 6.3.1).