A Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth (AV1-SIBO)

May 8, 2026 updated by: Brice Thompson, National University of Natural Medicine

An Open-Label Pilot 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97201
        • NUNM - Helfgott Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AV1PD1A
Multi-component dietary supplement taken 3 capsules daily for 8 weeks
Dietary supplement: AV1PD1A
Saccharomyces cerevisiae fermentate, N-acetyl-glucosamine, Saccharomyces boulardii, heat-killed Lactobacillus rhamnosus, methylcobalamin, berberine, ginger extract

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-emergent adverse events any grade, per CTCAE v5.0 (Common Terminology Criteria for Adverse Events)
Time Frame: From baseline/enrollment to the end of treatment at 8 weeks
The number of participants experiencing ≥1 treatment-emergent AE from first dose through end of treatment. Severity graded using CTCAE v5.0 (scale 1-5; 1 is least severe, 5 is most); relatedness assessed by the investigator. Report number of participants with any treatment-emergent AE and summarize by worst grade and relatedness.
From baseline/enrollment to the end of treatment at 8 weeks
Number of participants with laboratory abnormalities meeting pre-specified hold/stop criteria
Time Frame: Screening/baseline, Week 4, and Week 8
Count of participants who meet any lab-based stopping rule (e.g., ALT/AST ≥3× ULN, total bilirubin ≥2× ULN, ALP ≥2× ULN with cholestatic pattern, eGFR <60 mL/min/1.73 m² on repeat or ≥50% decline from baseline, ANC <1,000/µL, Hgb <8 g/dL, platelets <50,000/µL). ULN/LLN per local lab report.
Screening/baseline, Week 4, and Week 8
Number of participants requiring any dose modification/temporary hold/discontinuation
Time Frame: From first dose (Week 0) through end of treatment at Week 8.
Count of participants who undergo a dose reduction, temporary hold, or permanent discontinuation of the study product per the prespecified dose-modification algorithm (triggered by AEs or labs).
From first dose (Week 0) through end of treatment at Week 8.
Change in Patient Reported Outcomes Measurement Information System (PROMIS)-29+2 Profile v2.1 domain T-scores
Time Frame: From baseline/enrollment to the end of treatment at 8 weeks
T-scores range from 22.5 minimum to 79.4 maximum. For symptom domains (e.g., Pain Interference, Anxiety, Depression, Fatigue, Sleep Disturbance), higher scores = worse symptoms; for function domains (Physical Function; Ability to Participate in Social Roles and Activities), higher scores = better function. Outcome is a mean change from baseline to Week 8 for the specified single domain.
From baseline/enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in PROMIS Gastrointestinal Gas & Bloating Short Form 6a T-score
Time Frame: From baseline/enrollment to the end of treatment at 8 weeks
T-score range 20-80; higher = worse gas/bloating. Outcome is mean change from baseline to Week 8.
From baseline/enrollment to the end of treatment at 8 weeks
Change in PROMIS® Gastrointestinal Belly Pain Short Form 6a T-score
Time Frame: From baseline/enrollment to the end of treatment at 8 weeks
T-score range 20-80; higher = worse belly pain. Outcome is mean change from baseline to Week 8.
From baseline/enrollment to the end of treatment at 8 weeks
IBS-Adequate Relief (IBS-AR)
Time Frame: From baseline/enrollment to week 4, to the end of treatment at 8 weeks.
Proportion reporting adequate symptom relief at Week 4 and Week 8. The scale is a single dichotomous (yes/no) outcome from the question "Over the past week have you had adequate relief of your IBS symptoms?"
From baseline/enrollment to week 4, to the end of treatment at 8 weeks.
Change in 0-90-minute hydrogen rise (ppm) on lactulose breath test
Time Frame: From baseline/enrollment to the end of treatment at 8 weeks
Mean change in 0-90 min hydrogen rise (ppm) from baseline to Week 8.
From baseline/enrollment to the end of treatment at 8 weeks
Change in peak methane (ppm) on lactulose breath test
Time Frame: From baseline/enrollment to the end of treatment at 8 weeks
Mean change in peak methane (ppm) from baseline to Week 8. (Consensus: ≥10 ppm at any time indicates methane-positive.)
From baseline/enrollment to the end of treatment at 8 weeks
Number of participants with a negative lactulose breath test at Week 8
Time Frame: Week 8
Count of participants meeting negative criteria at Week 8 (e.g., hydrogen rise <20 ppm (0-90 min) and methane <10 ppm at all time points), per consensus thresholds.
Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Natural Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JG72425

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate, de-identified results will be disseminated; IPD may be considered upon reasonable request and IRB/DUA approvals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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