NCT07215676

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

An Open-Label Pilot Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: National University of Natural Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Prospective, single-site, open-label, single-group pilot conducted at NUNM's Helfgott Research Institute (Portland, OR). The investigational product (AV1PD1A) is a multi-component dietary supplement containing Saccharomyces cerevisiae fermentate (EpiCor), N-acetyl-glucosamine, Saccharomyces boulardii, Lactobacillus rhamnosus (heat-killed), methylcobalamin, berberine, and gingerol (ginger extract). Dosing: 3 capsules daily for 8 weeks. Primary outcome is safety/tolerability (labs, vitals, AEs). Exploratory outcomes include validated PROMIS instruments, IBS Adequate Relief, and changes in lactulose breath-test hydrogen/methane. Enrollment is single-arm with anticipated n = 10 (pilot) to establish feasibility/tolerability signals that inform future powered trials.

Conditions

• Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
• Small Intestinal Bacterial Overgrowth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	AV1PD1A	Saccharomyces cerevisiae fermentate, N-acetyl-glucosamine, Saccharomyces boulardii, heat-killed Lactobacillus rhamnosus, methylcobalamin, berberine, ginger extract

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2025-10-10
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States