Phase
Condition
N/ATreatment
CapScan collection capsule
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males or females 18 years of age or older and 80 years of age or younger at the timeof the first Screening Visit.
ASA Classification 1 or 2.
For women of childbearing potential, negative urine pregnancy test within 7 days ofScreening Visit.
Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declaredabstinence).
Subject is fluent in English and understands the study protocol and informed consentand is willing and able to comply with study requirements and sign the informedconsent 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
Exclusion Criteria:
History of any of the following: Prior gastric or esophageal surgery, including lapbanding or bariatric surgery, bowel obstruction, gastric outlet obstruction,diverticulitis, inflammatory bowel disease, ileostomy or colostomy, gastric oresophageal cancer, achalasia, esophageal diverticulum, active dysphagia orodynophagia.
Actively taking a proton-pump-inhibitor medication within 30 days of enrollment
Pregnancy or planned pregnancy within 30 days from Screening Visit, orbreast-feeding
Any form of active substance abuse or dependence (including drug or alcohol abuse),unstable medical or psychiatric disorder, or any chronic condition susceptible, inthe opinion of the investigator, to interfere with the conduct of the study
A clinical condition that, in the judgment of the investigator, could potentiallypose a health risk to the subject while involved in the study
Study Design
Study Description
Connect with a study center
Silicon Valley Gastroenterology
Mountain View, California 94040
United StatesActive - Recruiting
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