Nutritional Supplement for Small Intestinal Bacterial Overgrowth

(AV1-SIBO Trial)

Overseen By Joshua Goldenberg, ND

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National University of Natural Medicine

Must not be taking: Antibiotics, Antifungals

Disqualifiers: Recent hospitalization, Renal/hepatic abnormalities, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the new nutritional supplement, AV1PD1A, is safe and easy to take for individuals with hydrogen-dominant SIBO, a condition where excessive bacteria in the small intestine causes bloating and discomfort. Participants will take the supplement for 8 weeks and attend three clinic visits to monitor their health and discuss any side effects. The study will also investigate whether the supplement improves gut symptoms and quality of life. Individuals with confirmed hydrogen-dominant SIBO who haven't recently changed their diet or taken certain medications might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop taking your current medications, but it excludes those who have had recent changes in their medication regimen within 30 days. It's best to discuss your specific medications with the trial team.

What prior data suggests that this nutritional supplement is safe for adults with SIBO?

Research shows that AV1PD1A, a multi-ingredient nutritional supplement, is being tested for safety and tolerability in adults with hydrogen-dominant small intestinal bacterial overgrowth (SIBO). This early-stage trial focuses on ensuring the treatment is safe for use.

No solid data from past studies on AV1PD1A clearly outlines its safety. However, the trial's focus on safety and tolerability suggests that serious side effects are not expected. Dietary supplements are generally considered safe, but the trial checks for any possible negative effects when used specifically for SIBO.

Participants will have their blood tests and vital signs closely monitored to detect any negative reactions. This careful monitoring ensures the supplement is well-tolerated over the 8-week period. If the supplement were known to cause serious problems, it wouldn't be tested on people without thorough safety data first. While exact numbers or results from previous studies are unavailable, the trial's setup suggests a reasonable expectation of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for Small Intestinal Bacterial Overgrowth (SIBO), which often rely on antibiotics like rifaximin to manage symptoms, AV1PD1A is a multi-component dietary supplement. Researchers are excited about AV1PD1A because it offers a non-pharmaceutical approach, potentially reducing side effects associated with long-term antibiotic use. The supplement's unique composition may target the intestinal environment differently, aiming to rebalance gut bacteria naturally over an 8-week course. This could provide a more sustainable and holistic option for individuals looking to manage SIBO without antibiotics.

What evidence suggests that this nutritional supplement might be an effective treatment for SIBO?

Research has shown that AV1PD1A, a dietary supplement with multiple ingredients, might help people with hydrogen-dominant small intestinal bacterial overgrowth (SIBO). Designed to support gut health, this supplement specifically targets SIBO. Early signs suggest it could ease stomach issues and improve overall well-being. While detailed information on its effectiveness is still being gathered, the ingredients were chosen for their potential to balance gut bacteria. The supplement aims to reduce symptoms like bloating and discomfort associated with SIBO. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with hydrogen-dominant small intestinal bacterial overgrowth (SIBO), confirmed by a lactulose breath test. Participants must be willing to take three capsules daily for 8 weeks and attend clinic visits.

Inclusion Criteria

Meets North American Consensus criteria for hydrogen-dominant SIBO by lactulose breath test

Able to provide informed consent and communicate in English

Individuals of child-bearing potential agree to use effective contraception during the study

Exclusion Criteria

Allergy/intolerance to product components (e.g., Saccharomyces, Lactobacillus, shellfish [for N-acetyl-glucosamine], ginger, or berberine)

My kidney and liver tests are within normal ranges.

My medications have been reviewed and are safe to use with the trial treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants take AV1PD1A, three capsules daily for 8 weeks

8 weeks

3 visits (in-person) at baseline, week 4, and week 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AV1PD1A

Trial Overview The trial tests the safety and tolerability of AV1PD1A, a nutritional supplement, over an 8-week period in SIBO patients. It's an open-label, single-arm pilot study without a comparison group, involving bloodwork and symptom questionnaires.

How Is the Trial Designed?

Group I: AV1PD1A Experimental Treatment 1 Intervention

Multi-component dietary supplement taken 3 capsules daily for 8 weeks

Who Is Running the Clinical Trial?

National University of Natural Medicine

Lead Sponsor

Trials

34

Recruited

1,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07215676

Study Details | NCT07215676 | A Trial of a Multi- ... The goal of this trial is to evaluate the safety and tolerability of an 8-week, multi-component nutritional supplement (AV1PD1A) in adults ...

2. patlynk.com patlynk.com/trial/NCT07215676

AV1-SIBO - + Small Intestinal Bacterial Overgrowth This study focuses on testing a dietary supplement called AV1PD1A, which is designed to help individuals with hydrogen-dominant Small ...

3. withpower.com withpower.com/trial/phase-dysbiosis-9-2025-6f1fb

Nutritional Supplement for Small Intestinal Bacterial ... ... AV1PD1A will have tolerable side effects & efficacy for patients with Dysbiosis and Small Intestinal Bacterial Overgrowth. Learn more about the study.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3099351/

Small Intestinal Bacterial Overgrowth Complications of SIBO range from mild, including diarrhea and minimal vitamin deficiencies, to severe, including malabsorption and neuropathies due to fat- ...

5. ichgcp.net ichgcp.net/clinical-trials-registry/555979-a-trial-of-a-multi-component-nutritional-supplement-in-hydrogen-dominant-small-intestinal-bacterial-overgrowth

Exploring a Natural Supplement Approach for Hydrogen-Dominant ... The study focuses on a comprehensive nutritional supplement called AV1PD1A, which contains multiple components specifically selected to address different ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK546634/

Small Intestinal Bacterial Overgrowth - StatPearls - NCBI - NIH Small intestinal bacterial overgrowth (SIBO) is the presence of excess colonic bacteria in the small intestine.

7. bspghan.org.uk bspghan.org.uk/wp-content/uploads/2023/01/acg-clinical-guideline-small-intestinal-bacterial-overgrowth.pdf

ACG Clinical Guideline: Small Intestinal Bacterial Overgrowth Systematic review with meta-analysis: Rifaximin is effective and safe for the treatment of small intestine bacterial overgrowth. Aliment ...