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 @ 5:07 AM
Ignite Modification Date:
2025-12-25 @ 5:07 AM
NCT ID:
NCT00093327
Eligibility Criteria:
Inclusion Criteria:
* Irritable bowel syndrome of moderate severity for at least 12 weeks within 1 year prior to study entry
* Colonoscopy or flexible sigmoidoscopy/air contrast barium enema within 5 years prior to study entry
* Able to walk
* Able and willing to cooperate with the study
* Sufficient knowledge of English to be able to participate in the study
Exclusion Criteria:
* Medications that affect the gastrointestinal tract or visceral sensation, unless the participant is on a stable dose for at least 1 month prior to study entry and for the duration of the study
* History of severe or intractable IBS
* History of acupuncture treatment
* Score between 37 and 150 on the Functional Bowel Disorder Severity Index (FBDSI)
* Any concomitant bowel problem that would interfere with the study
* History of laxative abuse
* Abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry
* History of metabolic or inflammatory disease that may affect bowel movement
* History of significant psychiatric, neurological, metabolic, hepatic, renal, infectious, hematological, cardiovascular, gastrointestinal, or pulmonary illness. Participants who are stable for more than 1 year with conditions that will not interfere with the study are not excluded.
* History of drug or alcohol abuse within 2 years prior to study entry
* Positive for opiates at the initial visit drug screen
* Abnormal vital signs, physical examination results, or clinical laboratory values, unless these abnormalities are judged to be clinically insignificant
* Pregnancy or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00093327
Study Brief:
Protocol Section:
NCT00093327