Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT00945334
Eligibility Criteria:
Inclusion Criteria:
* Rome III positive IBS subjects (18-75 years of age)
* Meet criteria for constipation predominant IBS symptoms including ≤ 3 complete spontaneous bowel movements per week with hard or lumpy stools.
* Presence of detectable methane on single breath sample (≥ 3ppm).
* If subjects are ≥ 50 years old, a colonoscopy had to have been completed within the past 5 years.
Exclusion Criteria:
* Subjects with history of intestinal surgery (except appendectomy or cholecystectomy)
* Recent antibiotic use (within the last 30 days)
* Subjects with known pelvic floor dysfunction
* Pregnancy
* Creatinine level \> 1.4
* Poorly controlled/uncontrolled significant medical condition that would interfere with study procedures
* Subjects with hearing loss and/or tinnitus
* History of bowel obstruction
* History of celiac disease
* History of inflammatory bowel disease
* Cirrhosis
* Diabetes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00945334
Study Brief:
Protocol Section:
NCT00945334