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

NCT06298409 | Recruiting Phase 1

• 1 other identifier: EB04
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Small Intestinal Bacterial Overgrowth

Outcome Measures

Primary Outcomes (2)

• Sampling of gut microbiota

  \> 75% of the retrieved CapScan devices to provide at least 3 million metagenomic DNA sequencing reads of gut microbes from the intestinal tract, and at least 900 annotated gut metabolites.

  56 days

• Sampling of gut metabolome

  \>75% of the retrieved CapScan devices to provide at least 900 annotated gut metabolites.

  56 days

Secondary Outcomes (2)

• Effect of rifaximin on gut microbiota

  56 days

• Effect of rifaximin on gut metabolome

  56 days

Interventions

CapScan collection capsule DEVICE

The CapScan collection capsule is a single-use device that collects fluids from the gastrointestinal tract for analysis ex-vivo.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Envivo Bio Inc: lead

Study Sites (1)

Silicon Valley Gastroenterology

Mountain View, California, 94040, United States

RECRUITING

Study Officials

• George Triadafilopoulos

  Silicon Valley Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Taufui

CONTACT

(650) 988-7530; svgistaff@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 7, 2024
• Study Start: February 15, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)