NCT06298409 · Envivo Bio Inc
Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®
What this study is about
We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)
View original scientific description
We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)
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
\> 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 metabolome
Time frame: 56 days
\>75% of the retrieved CapScan devices to provide at least 900 annotated gut metabolites.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Mountain View, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2025 · Source of record for eligibility and locations