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:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2025-12-26 @ 10:44 PM
NCT ID:
NCT00269412
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subject 18 years of age or older.
2. Irritable bowel syndrome confirmed by the Rome II Criteria
3. Lower endoscopic examination that demonstrates normal colonic anatomy
Exclusion Criteria:
1. Subject has exclusively constipation-predominant IBS (CIBS) that is characterized by \< 3 bowel movements/week or hard and lumpy stools.
2. Subject has alternating IBS, but is currently presenting with constipation associated IBS symptoms.
3. Subject has had adequate control of their DIBS and their symptom of bloating the week preceding the screening visit or at the time of randomization. Bloating includes the following symptoms: abdominal fullness, bloating, gas, or swelling.
4. Subjects has a positive stool culture for O \& P (ovum and parasite) and/or Clostridium difficile
5. Subject has failed to record 2 negative weekly global assessments during the past 10 days prior to randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00269412
Study Brief:
Protocol Section:
NCT00269412