RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2024-02-15

Study Completion:2025-07-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06298409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Jennifer Taufui

CONTACT

(650) 988-7530

svgistaff@gmail.com

Principal Investigator

George Triadafilopoulos

PRINCIPAL_INVESTIGATOR

Silicon Valley Gastroenterology

Study Locations (Sites)

Silicon Valley Gastroenterology

Mountain View, California, 94040

United States

Collaborators and Investigators

Sponsor: Envivo Bio Inc

George Triadafilopoulos, PRINCIPAL_INVESTIGATOR, Silicon Valley Gastroenterology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-15

Study Completion Date2025-07-01

Study Record Updates

Study Start Date2024-02-15

Study Completion Date2025-07-01

Terms related to this study

Additional Relevant MeSH Terms

Small Intestinal Bacterial Overgrowth