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:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT00065403
Eligibility Criteria:
Inclusion criteria:
Diagnosis of Irritable Bowel Syndrome based on Rome II criteria, including at least 12 weeks of abdominal discomfort or pain in the last 12 months with at least 2 of the following features:
* Relief with defecation
* Onset associated with a change in stool frequency
* Onset associated with a change in form/appearance of stool
Exclusion criteria:
* History of severe or intractable IBS, defined as continuous, unremitting and several abdominal pain greater than 12 hours/day
* Previous acupuncture treatment
* Concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study
* History of laxative abuse
* Previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable)
* History of metabolic or inflammatory disease that may affect bowel motility, eg.g., inflammatory bowel disease, diabetes mellitus, sarcoidosis
* Other significant illness as determined by Investigator
* History of drug or alcohol abuse w/in 2 years;
* Insufficient knowledge of English to complete self-assessments to participate in study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00065403
Study Brief:
Protocol Section:
NCT00065403