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Could a daily supplement soothe SIBO? small trial tests safety

NCT ID NCT07215676

Symptom relief Sponsor: National University of Natural Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This pilot study tested an 8-week course of a multi-ingredient nutritional supplement (AV1PD1A) in 9 adults with hydrogen-dominant small intestinal bacterial overgrowth (SIBO). The main goal was to see if the supplement was safe and tolerable. Participants took three capsules daily and were monitored with blood tests, symptom questionnaires, and breath tests. Because this was a small, open-label trial with no placebo group, it can only hint at whether the supplement might help—not prove it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AV1PD1A (a blend of yeast fermentate, N-acetyl-glucosamine, probiotics, vitamin B12, berberine, and ginger extract)
What this could lead to
If this supplement proves safe and well-tolerated, it could point toward a new dietary approach to ease SIBO symptoms.
What could go wrong
This was a very small pilot study with only 9 participants and no comparison group. The results may not apply to everyone, and the supplement's effectiveness is still uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

9 people

The number who actually took part.

Started

Oct 2025

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Dysbiosis small intestinal bacterial overgrowth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Small intestinal bacterial overgrowth Small intestinal bacterial overgrowth syndrome (SIBO)

Contacts and locations

Locations

  • NUNM - Helfgott Research Institute

    Portland, Oregon, 97201, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.