Recruiting soon
AV1-SIBO

Nutritional Supplement for Hydrogen-Dominant Small Intestinal Bacterial Overgrowth

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Study AimThis study aims to determine if a specific nutritional supplement can effectively manage symptoms in individuals with hydrogen-dominant small intestinal bacterial overgrowth.
What is being tested

AV1PD1A

Dietary Supplement
Who is being recruted

Pathologic Processes

+ Pathological Conditions, Signs and Symptoms
+ Dysbiosis
Over 18 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorNational University of Natural Medicine
Study ContactJoshua Goldenberg, ND
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2025Actual date on which the first participant was enrolled.

This study focuses on testing a dietary supplement called AV1PD1A, which is designed to help individuals with hydrogen-dominant Small Intestinal Bacterial Overgrowth (SIBO). This type of SIBO is a condition where there is an excessive growth of certain bacteria in the small intestine, leading to symptoms like bloating and discomfort. The supplement includes various components such as Saccharomyces cerevisiae fermentate, N-acetyl-glucosamine, and ginger extract, among others. The study seeks to determine the safety and tolerability of this supplement. It is important because it could offer a new approach to managing SIBO, potentially improving symptoms and quality of life for those affected. Participants in this study will take 3 capsules of the supplement daily for 8 weeks. The study aims to monitor the safety of the supplement by looking at lab results, vital signs, and any adverse effects experienced by the participants. Additionally, the study will explore other outcomes such as the impact on symptoms using specific questionnaires and changes in breath-test results for hydrogen and methane, which are indicators of SIBO. As a pilot study with a small group of 10 participants, it helps to gather initial data that could guide more extensive research in the future.

Official TitleAn Open-Label Pilot Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth 
NCT07215676
Principal SponsorNational University of Natural Medicine
Study ContactJoshua Goldenberg, ND
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
10 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pathologic Processes
Pathological Conditions, Signs and Symptoms
Dysbiosis
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Multi-component dietary supplement taken 3 capsules daily for 8 weeks

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

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.

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.

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).

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.
Secondary Objectives

T-score range 20-80; higher = worse gas/bloating. Outcome is mean change from baseline to Week 8.

T-score range 20-80; higher = worse belly pain. Outcome is mean change from baseline to Week 8.

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?"

Mean change in 0-90 min hydrogen rise (ppm) from baseline to Week 8.

Mean change in peak methane (ppm) from baseline to Week 8. (Consensus: ≥10 ppm at any time indicates methane-positive.)

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
NUNM - Helfgott Research InstitutePortland, United StatesSee the location
Recruiting soonOne Study Center