Actively Recruiting
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
Led by Envivo Bio Inc · Updated on 2025-06-11
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of the antibiotic rifaximin on the gut microbiota and metabolic profiles in patients diagnosed with Small Intestinal Bacterial Overgrowth (SIBO). The study uses the CapScan collection capsule, a device designed to sample intestinal fluids for detailed analysis. The trial is a prospective, open-label, single-arm, non-randomized, multi-center study focusing on understanding how rifaximin treatment may alter gut bacterial composition and metabolism in people with SIBO. Participants will use the CapScan collection capsule to collect samples from their gastrointestinal tract. They will receive a prescribed two-week course of rifaximin for SIBO, which they must not have started before enrollment. The study includes a 56-day period during which the gut microbiota and metabolome are sampled and analyzed to assess changes associated with rifaximin treatment. Throughout the study, participants will undergo assessments including microbiome sampling and metabolic profiling using the CapScan capsule. Researchers will monitor changes in gut bacteria and metabolites over 56 days to measure the effects of rifaximin. Participants must comply with study requirements, including contraception for women of childbearing potential and completing study visits within the designated timeframe. The study aims to gather detailed information on how rifaximin influences gut microbial communities and their metabolic products in SIBO patients.
CONDITIONS
Brief Title
Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 56 days
Participants use the CapScan collection capsule device to collect gastrointestinal fluids for analysis.
Multiple visits during the 56-day period to use the capsule and collect samples
Trial Site Locations
Total: 1 location
1
Silicon Valley Gastroenterology
Mountain View, California, United States, 94040
Actively Recruiting
Research Team
J
Jennifer Taufui
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
0
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