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

Launched by ENVIVO BIO INC · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called Rifaximin affects the gut bacteria and metabolites in patients with Small Intestinal Bacterial Overgrowth, commonly known as SIBO. The researchers will collect samples from the intestines using a special capsule to better understand how the treatment works. The trial is currently looking for participants between the ages of 18 and 80 who have symptoms of SIBO and have been prescribed Rifaximin but have not yet started taking it.

To be eligible, participants need to be fluent in English and willing to follow the study rules, including using effective birth control if they can become pregnant. They should also have a positive breath test that indicates SIBO. However, people with certain medical histories or conditions, such as previous surgeries on the stomach or intestines, or those who are pregnant or breastfeeding, will not be able to participate. Those who join can expect to undergo some testing and monitoring during the study to help researchers learn more about how Rifaximin works for SIBO.

Gender

ALL

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