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NCT07215676 · ClinicalTrials.gov registry record · NA
A Trial of a Multi-Component Nutritional Supplement in Hydrogen-Dominant Small Intestinal Bacterial Overgrowth
A NA study, sponsored by National University of Natural Medicine.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT07215676: Completed NA study, sponsored by National University of Natural Medicine.
NCT07215676 is a NA study that has completed, run by National University of Natural Medicine. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07215676, a NA study, has completed, sponsored by National University of Natural Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study 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: 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.
Primary Outcome
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.
Interventions
- DIETARY_SUPPLEMENT AV1PD1A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2025-10-10 |
| Est. Completion | 2026-02-25 |
| Phase | NA |
What the finished NCT07215676 record still lists
NCT07215676 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which AV1PD1A is the first listed.
NCT07215676 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07215676 about?
NCT07215676 is a clinical study titled "A 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...
What is the current status of trial NCT07215676?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2025-10-10. Estimated completion is 2026-02-25.
What interventions are being tested in trial NCT07215676?
The interventions under investigation include: AV1PD1A (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07215676?
This trial is sponsored by National University of Natural Medicine, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07215676's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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