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

Small Intestinal Bacterial Overgrowth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06298409
• Other study ID #: EB04
• Status: Recruiting
• Start date: February 15, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2024
• Source: Envivo Bio Inc
• Contact: Jennifer Taufui
• Phone: (650) 988-7530
• Email: svgistaff[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Small Intestinal Bacterial Overgrowth

Intervention

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

Locations

Country	Name	City	State
United States	Silicon Valley Gastroenterology	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Envivo Bio Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Sampling of gut metabolome	>75% of the retrieved CapScan devices to provide at least 900 annotated gut metabolites.	56 days
Secondary	Effect of rifaximin on gut microbiota	Determine the effect of rifaximin on the regional compositions of the gut microbiota among SIBO patients by assessing the diversity, centroids and distributions of microbial taxa from sequenced CapScan samples of each subject before and after rifaximin at 5 time points.	56 days
Secondary	Effect of rifaximin on gut metabolome	Determine the effect of rifaximin on the regional compositions of the gut metabolites among SIBO patients by assessing the changes to metabolite classes and metabolic pathways as measured by LC/MS-MS analysis of CapScan samples for each subject before and after rifaximin at 5 time points.	56 days