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 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT01620606
Eligibility Criteria:
Inclusion Criteria:
* The child is 7 to 12 years old
* The child experienced at least three episodes of unexplained abdominal pain over a three month period which affected the child's activities
* The child lived with the primary caregiver for at least the last 3 months
* The child and the parent agree to the conditions of study participation, including randomization, participation in intervention and follow-up evaluations
* The parent and child comprehend and speak English without assistance
Exclusion Criteria:
* The child has positive physical or laboratory findings which would explain the abdominal pain
* The child has a chronic disease (e.g. Crohn's, ulcerative colitis, pancreatitis, diabetes, epilepsy, etc.)
* The child is lactose intolerant
* The child had major surgery in the past year
* The parent or child has developmental disabilities that require full-time special education or that impair ability to respond to assessment measures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
12 Years
Study:
NCT01620606
Study Brief:
Protocol Section:
NCT01620606