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 @ 3:55 AM
Ignite Modification Date:
2025-12-25 @ 3:55 AM
NCT ID:
NCT01887002
Eligibility Criteria:
Inclusion Criteria:
1. Female 18-65 years of age (inclusive)
2. Diagnosed with IBS based on the following criteria (Rome III criteria):
* Symptom onset at least 6 months prior to diagnosis, and
* Recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and
* Abdominal discomfort or pain associated with two or more of the following at least 25% of the time:
* improvement with defecation
* onset associated with a change in frequency of stool/defecation
* onset associated with a change in form (appearance) of stool
3. Diagnosed with IBS-D, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations
Exclusion Criteria:
* Any structural abnormality of the gastrointestinal (GI) tract (other than esophagitis or gastritis)
* History of Chron's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper GI symptoms that may impact the assessment of IBS symptoms
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01887002
Study Brief:
Protocol Section:
NCT01887002