A Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth

Completed · Not applicable

Conditions studied: Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Small Intestinal Bacterial Overgrowth

In brief

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.

Key facts

Study ID

NCT07215676

Run by

National University of Natural Medicine

People needed

9

Starts

2025-10-10

Expected to finish

2026-02-25

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• NUNM - Helfgott Research Institute — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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