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

NCT07215676 | Not Yet Recruiting

• 1 other identifier: JG72425
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

SIBO; small intestinal bacterial overgrowth; hydrogen SIBO; dysbiosis; probiotic; postbiotic

Outcome Measures

Primary Outcomes (4)

• Number of participants with treatment-emergent adverse events any grade, per CTCAE v5.0 (Common Terminology Criteria for Adverse Events)

  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

  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

  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

  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 Outcomes (6)

• Change in PROMIS Gastrointestinal Gas & Bloating Short Form 6a T-score

  From baseline/enrollment to the end of treatment at 8 weeks

• Change in PROMIS® Gastrointestinal Belly Pain Short Form 6a T-score

  From baseline/enrollment to the end of treatment at 8 weeks

• IBS-Adequate Relief (IBS-AR)

  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

  From baseline/enrollment to the end of treatment at 8 weeks

• Change in peak methane (ppm) on lactulose breath test

  From baseline/enrollment to the end of treatment at 8 weeks

Study Arms (1)

AV1PD1A

EXPERIMENTAL

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

Dietary Supplement: AV1PD1A

Interventions

AV1PD1A DIETARY_SUPPLEMENT

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

AV1PD1A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Natural Medicine: lead

Study Sites (1)

NUNM - Helfgott Research Institute

Portland, Oregon, 97201, United States

Location

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Joshua Goldenberg, ND

CONTACT

503-552-1552; jgoldenberg@nunm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)