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

Last updated: July 19, 2024
Sponsor: Envivo Bio Inc
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

CapScan collection capsule

Clinical Study ID

NCT06298409
EB04
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males or females 18 years of age or older and 80 years of age or younger at the timeof the first Screening Visit.

  • ASA Classification 1 or 2.

  • For women of childbearing potential, negative urine pregnancy test within 7 days ofScreening Visit.

  • Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declaredabstinence).

  • Subject is fluent in English and understands the study protocol and informed consentand is willing and able to comply with study requirements and sign the informedconsent 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

Exclusion Criteria:

  • History of any of the following: Prior gastric or esophageal surgery, including lapbanding or bariatric surgery, bowel obstruction, gastric outlet obstruction,diverticulitis, inflammatory bowel disease, ileostomy or colostomy, gastric oresophageal cancer, achalasia, esophageal diverticulum, active dysphagia orodynophagia.

  • Actively taking a proton-pump-inhibitor medication within 30 days of enrollment

  • Pregnancy or planned pregnancy within 30 days from Screening Visit, orbreast-feeding

  • Any form of active substance abuse or dependence (including drug or alcohol abuse),unstable medical or psychiatric disorder, or any chronic condition susceptible, inthe opinion of the investigator, to interfere with the conduct of the study

  • A clinical condition that, in the judgment of the investigator, could potentiallypose a health risk to the subject while involved in the study

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: CapScan collection capsule
Phase: 1
Study Start date:
February 15, 2024
Estimated Completion Date:
July 01, 2025

Study 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.

Connect with a study center

  • Silicon Valley Gastroenterology

    Mountain View, California 94040
    United States

    Active - Recruiting

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