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

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.

NCT Number	NCT07215676
Lead Sponsor	National University of Natural Medicine
Conditions	Small Intestinal Bacterial Overgrowth Syndrome (SIBO), Small Intestinal Bacterial Overgrowth
Enrollment	9 participants
Start Date	2025-10-10
Primary Completion	2026-02-25 (estimated)
Study Completion	2026-02-25 (estimated)
Updated on ClinicalTrials.gov	2026-05-12