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Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan® | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®

Evaluating the Effect of Rifaximin on the Regional Composition of the Gut Microbiota and Metabolic Profiles of Subjects With SIBO Using the CapScan® Collection Capsule

NCT06298409•Envivo Bio Inc

View on ClinicalTrials.gov

Summary

We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)

Detailed Description

Prospective, open-label, single-arm, non-randomized, multi-center study designed to evaluate the effect of the antibiotic rifaximin on the regional composition of the gut microbiota and metabolic profiles of subjects diagnosed with SIBO, using the CapScan collection capsule.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or females 18 years of age or older and 80 years of age or younger at the time of the first Screening Visit.
•ASA Classification 1 or 2.
•For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit.
•Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).
•Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.
•Positive for at least one clinical symptom consistent with SIBO.
•Positive lactulose breath test for SIBO, by Hydrogen (H2) criteria.
•Prescribed, but has not started, a two-week course of Rifaximin for SIBO.

Exclusion Criteria

•History of any of the following: Prior gastric or esophageal surgery, including lap banding or bariatric surgery, bowel obstruction, gastric outlet obstruction, diverticulitis, inflammatory bowel disease, ileostomy or colostomy, gastric or esophageal cancer, achalasia, esophageal diverticulum, active dysphagia or odynophagia.
•Actively taking a proton-pump-inhibitor medication within 30 days of enrollment
•Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding
•Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study
•A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study

Locations (1)

Silicon Valley Gastroenterology

Mountain View, California, United States

Key Dates

Start Date

February 15, 2024

Primary Completion Date

February 28, 2026

Completion Date

February 28, 2026

Last Updated

June 11, 2025

Enrollment

ESTIMATED participants

Conditions

Small Intestinal Bacterial Overgrowth

Interventions

CapScan collection capsule

DEVICE

Contacts

Jennifer Taufui

CONTACT

(650) 988-7530 svgistaff@gmail.com

Combined Lactulose H2-breath Test With Abdominal Imaging

NCT07145580

Food Intolerance SyndromesSmall Intestinal Bacterial Overgrowth Syndrome (SIBO)+1 more

View study

COMPLETED

Small Intestinal Bacterial Overgrowth in Critically Ill Patients

NCT05765994

Small Intestinal Bacterial OvergrowthCritical Illness+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®

Inclusion Criteria

Exclusion Criteria

Combined Lactulose H2-breath Test With Abdominal Imaging

Small Intestinal Bacterial Overgrowth in Critically Ill Patients

Novel Supplement-based Therapy for the Treatment of Small Intestinal Bacterial Overgrowth

Comparative Assessment of Radioisotope Glucose and Breath Test

Characteristic of Intestinal Flora in Male Elderly With Small Intestinal Bacterial Overgrowth