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

NCT07215676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

AV1PD1A

Saccharomyces cerevisiae fermentate, N-acetyl-glucosamine, Saccharomyces boulardii, heat-killed Lactobacillus rhamnosus, methylcobalamin, berberine, ginger extract

Sponsors & Collaborators

  • National University of Natural Medicine

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-10
Primary Completion
2026-02-25
Completion
2026-02-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07215676 on ClinicalTrials.gov