Evaluating the Effect Of Rifaximin on the Gut Microbiota and Metabolome in SIBO Using CapScan®
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEnvivo Bio Inc
About this trial
We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- CapScan collection capsule
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov