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

NCT ID: NCT07215676

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-09-30

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

AV1PD1A

Multi-component dietary supplement taken 3 capsules daily for 8 weeks

Group Type: EXPERIMENTAL

AV1PD1A

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

AV1PD1A

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Natural Medicine

OTHER

Sponsor Role: lead

Responsible Party

Brice Thompson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

NUNM - Helfgott Research Institute

Portland, Oregon, United States

Countries

United States

Central Contacts

Joshua Goldenberg, ND

Role: CONTACT

jgoldenberg@nunm.edu

503-552-1552

Facility Contacts

Brice Thompson, ND, MS

Role: primary

bthompson@nunm.edu

503-893-2451

Other Identifiers

JG72425

Identifier Type: -

Identifier Source: org_study_id