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Recruiting NCT06298409

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

Phase I Interventional Small Intestinal Bacterial Overgrowth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CapScan collection capsule.
Who it may be relevant to
Registry conditions: Small Intestinal Bacterial Overgrowth. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Detailed 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.

Interventions

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

Primary outcome measures

  • Sampling of gut microbiota [Time frame: 56 days]
  • Sampling of gut metabolome [Time frame: 56 days]
Secondary outcome measures (2)
  • Effect of rifaximin on gut microbiota [Time frame: 56 days]
  • Effect of rifaximin on gut metabolome [Time frame: 56 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Silicon Valley Gastroenterology — Mountain View

Identifiers

NCT: NCT06298409 · EB04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗