A Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacteri… (NCT07215676) | Clinical Trial Compass
CompletedNot Applicable
A Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth
United States9 participantsStarted 2025-10-10
Plain-language summary
The goal of this trial is to evaluate the safety and tolerability of an 8-week, multi-component nutritional supplement (AV1PD1A) in adults with hydrogen-dominant small intestinal bacterial overgrowth (SIBO).
The main questions the study aims to answer are:
1. Is the product safe and well-tolerated over 8 weeks, as measured by bloodwork, vital signs, and adverse effects?
2. How many participants adhere to the intervention without a dose modification, hold, or discontinuation?
Exploratory questions include: do GI symptoms and quality of life ratings improve, and do hydrogen/methane levels on lactulose breath testing change from baseline to week 8?
There is no comparison group; this is a prospective, open-label, single-arm pilot trial (n=10).
Participants will:
* Be screened and confirmed to have hydrogen-dominant SIBO by lactulose breath test (with 24-hour prep diet and overnight fast).
* Take AV1PD1A, three capsules daily for 8 weeks.
* Attend three clinic visits at baseline, week 4, and week 8 for vital measurements, fasting blood draws, and adverse event checks.
* Complete questionnaires on symptoms and quality of life.
* Repeat the lactulose breath test at week 8 to assess changes in hydrogen and methane.
Who can participate
Age range
18 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:
* Adults ≥ 18 years.
* Meets North American Consensus criteria for hydrogen-dominant SIBO by lactulose breath test.
* Willing to: take study supplement (3 caps/day for 8 weeks); complete two lactulose breath tests with required prep/fast; undergo three fasting blood draws; complete questionnaires.
* Able to provide informed consent and communicate in English.
* Individuals of child-bearing potential agree to use effective contraception during the study.
Exclusion Criteria:
* Recent antibiotics/antifungals/supplements that confound breath test results (e.g., antibiotics within 14 days before breath test; current systemic or topical antifungals).
* Recent changes in diet/medications/supplement regimen within 30 days.
* Hospitalization within past 3 months.
* Allergy/intolerance to product components (e.g., Saccharomyces, Lactobacillus, shellfish \[for N-acetyl-glucosamine\], ginger, or berberine).
* Renal/hepatic abnormalities at screening (e.g., eGFR \<60 mL/min/1.73 m2; AST/ALT/bilirubin outside of normal reference ranges).
* Hepatitis from any cause; excessive alcohol use (\>7 drinks/week women; \> 14 drinks/week men).
* Medications with concerning interactions after clinical investigator review
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
Number of participants with treatment-emergent adverse events any grade, per CTCAE v5.0 (Common Terminology Criteria for Adverse Events)
Timeframe: From baseline/enrollment to the end of treatment at 8 weeks
2
Number of participants with laboratory abnormalities meeting pre-specified hold/stop criteria
Timeframe: Screening/baseline, Week 4, and Week 8
3
Number of participants requiring any dose modification/temporary hold/discontinuation
Timeframe: From first dose (Week 0) through end of treatment at Week 8.
4
Change in Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 domain T-scores
Timeframe: From baseline/enrollment to the end of treatment at 8 weeks