An Open-Label Pilot Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- Number of participants with treatment-emergent adverse events any grade, per CTCAE v5.0 (Common Terminology Criteria for Adverse Events)
Study Overview
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:
- Is the product safe and well-tolerated over 8 weeks, as measured by bloodwork, vital signs, and adverse effects?
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AV1PD1A
Multi-component dietary supplement taken 3 capsules daily for 8 weeks
Intervention: AV1PD1A (Dietary Supplement)
Outcomes
Primary Outcomes
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.
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.
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).
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.
Secondary Outcomes
- 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 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 PROMIS Gastrointestinal Gas & Bloating Short Form 6a T-score(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)
- Number of participants with a negative lactulose breath test at Week 8(Week 8)
Investigators
Brice Thompson
Principal Investigator
National University of Natural Medicine