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

Envivo Bio

Status and phase

Enrolling

Phase 1

Conditions

Small Intestinal Bacterial Overgrowth

Treatments

Device: CapScan collection capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT06298409

EB04

Details and patient eligibility

About

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

Full 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.

Enrollment

34 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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