NCT06298409 Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®
| NCT ID | NCT06298409 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Envivo Bio Inc |
| Condition | Small Intestinal Bacterial Overgrowth |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2024-02-15 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 34 participants in total. It began in 2024-02-15 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)
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
Contact & Investigator
George Triadafilopoulos
PRINCIPAL INVESTIGATOR
Silicon Valley Gastroenterology
Frequently Asked Questions
Who can join the NCT06298409 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Small Intestinal Bacterial Overgrowth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06298409 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06298409 currently recruiting?
Yes, NCT06298409 is actively recruiting participants. Contact the research team at svgistaff@gmail.com for enrollment information.
Where is the NCT06298409 trial being conducted?
This trial is being conducted at Mountain View, United States.
Who is sponsoring the NCT06298409 clinical trial?
NCT06298409 is sponsored by Envivo Bio Inc. The principal investigator is George Triadafilopoulos at Silicon Valley Gastroenterology. The trial plans to enroll 34 participants.