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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 is a NA study that has completed, run by National University of Natural Medicine. The registered enrollment target is 9 participants.
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.
Interventions
- DIETARY_SUPPLEMENT AV1PD1A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2025-10-10 |
| Est. Completion | 2026-02-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07215676
The ClinicalTrials.gov registry entry for NCT07215676 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National University of Natural Medicine, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AV1PD1A is the first listed.
NCT07215676 reports 0 study locations.
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.
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