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 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT03134950
Eligibility Criteria:
Inclusion Criteria:
* diagnosed with functional abdominal pain by a pediatric gastroenterologist
* clinically significant disability evidenced by a total score of \> 7 on the Functional Disability Inventory (FDI) that remains elevated (\>2) after 2 weeks
Exclusion Criteria:
* significant medical condition(s) with an identifiable organic cause (e.g., Inflammatory Bowel Diseases such as Ulcerative Colitis and Chron's Disease)
* documented developmental delay, severe cognitive impairment, or a thought disorder
* evidence of severe depressive symptoms (CDI 2: T score \>80) and/or active suicidal ideation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
14 Years
Study:
NCT03134950
Study Brief:
Protocol Section:
NCT03134950