AV1-SIBONutritional Supplement for Hydrogen-Dominant Small Intestinal Bacterial Overgrowth
This study aims to determine if a specific nutritional supplement can effectively manage symptoms in individuals with hydrogen-dominant small intestinal bacterial overgrowth.
AV1PD1A
Pathologic Processes
+ Pathological Conditions, Signs and Symptoms
+ Dysbiosis
Other Study
Summary
Study start date: October 1, 2025
Actual date on which the first participant was enrolled.This study focuses on testing a dietary supplement called AV1PD1A, which is designed to help individuals with hydrogen-dominant Small Intestinal Bacterial Overgrowth (SIBO). This type of SIBO is a condition where there is an excessive growth of certain bacteria in the small intestine, leading to symptoms like bloating and discomfort. The supplement includes various components such as Saccharomyces cerevisiae fermentate, N-acetyl-glucosamine, and ginger extract, among others. The study seeks to determine the safety and tolerability of this supplement. It is important because it could offer a new approach to managing SIBO, potentially improving symptoms and quality of life for those affected. Participants in this study will take 3 capsules of the supplement daily for 8 weeks. The study aims to monitor the safety of the supplement by looking at lab results, vital signs, and any adverse effects experienced by the participants. Additionally, the study will explore other outcomes such as the impact on symptoms using specific questionnaires and changes in breath-test results for hydrogen and methane, which are indicators of SIBO. As a pilot study with a small group of 10 participants, it helps to gather initial data that could guide more extensive research in the future.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location