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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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• 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.

Locations
United States
California
Silicon Valley Gastroenterology
RECRUITING
Mountain View
Contact Information
Primary
Jennifer Taufui
svgistaff@gmail.com
(650) 988-7530
Time Frame
Start Date: 2024-02-15
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 34
Related Therapeutic Areas
Sponsors
Leads: Envivo Bio Inc

This content was sourced from clinicaltrials.gov