Evaluating rifaximin's effect on gut microbiota in SIBO patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess how the antibiotic rifaximin influences the gut microbiota and metabolic profiles in patients diagnosed with Small Intestinal Bacterial Overgrowth (SIBO). It employs a microbiome sampling capsule, CapScan, to collect intestinal microbiota samples from participants. The study is designed as a prospective, open-label, single-arm, non-randomized, multi-center approach, focusing on individuals who have been prescribed rifaximin but have not yet started treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• Silicon Valley Gastroenterology
  Mountain View, California, United States Recruiting

Study contacts

• Principal investigator: George Triadafilopoulos — Silicon Valley Gastroenterology
• Study coordinator: Jennifer Taufui
• Email: svgistaff@gmail.com
• Phone: (650) 988-7530

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using fecal microbiota transplant to treat small intestinal bacterial overgrowth in children

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  Recruiting Phase 1 McMaster Children's Hospital · Hamilton, Ontario and 1 other locations · NCT05967871

• Registry for gastrointestinal motility disorders at Indiana University

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.