Status:
NOT_YET_RECRUITING
A Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth
Lead Sponsor:
National University of Natural Medicine
Conditions:
Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07215676
Start Date
October 1 2025
End Date
September 1 2026
Last Update
October 10 2025
Active Locations (1)
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1
NUNM - Helfgott Research Institute
Portland, Oregon, United States, 97201