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Rifaximin and Gut Health in SIBO Study

This study is looking at how the antibiotic rifaximin affects the bacteria and other substances (metabolome) in the gut of people with Small Intestinal Bacterial Overgrowth (SIBO). Researchers will use a special capsule called CapScan to collect samples from your digestive tract. The main goal is to see how your gut bacteria and metabolome change after taking rifaximin. To join, you must be between 18 and 80 years old. The study aims to enroll 34 participants, but its current recruitment status is unclear. Success will be measured by changes in your gut microbiota and metabolome after 56 days.

Study design
This is an open-label, single-arm study, meaning all 34 participants will receive the same treatment and everyone will know what treatment they are getting. It is not randomized.
What's involved
You will have samples collected from your gut using a CapScan capsule. The primary endpoints for sampling gut microbiota and metabolome are at 56 days.
Compensation
Not stated in the trial record.
Follow-up
Your gut microbiota and metabolome will be sampled at 56 days to see the effects of the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06298409

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

Recruiting
PHASE1Ages 18–80InterventionalBasic science
Envivo Bio Inc
~34 participants
Updated 2025-06-11 on ClinicalTrials.gov
What's tested:CapScan collection capsule

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sampling of gut microbiota
Measured over 56 days
+1 more outcome measured

Conditions

Small Intestinal Bacterial Overgrowth

Explore related trials

Small intestinal bacterial overgrowth

NCT06298409

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Silicon Valley Gastroenterology

    Mountain View, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • George Triadafilopoulos · PRINCIPAL_INVESTIGATOR · Silicon Valley Gastroenterology

Who to contact

Jennifer Taufui
[email protected]
(650) 988-7530
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Sampling of gut microbiota56 days

    \> 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.

  • Sampling of gut metabolome56 days

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