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 @ 4:26 PM
Ignite Modification Date:
2025-12-24 @ 4:26 PM
NCT ID:
NCT01498666
Eligibility Criteria:
Inclusion Criteria:
* FAP (Functional Abdominal Pain) according to Rome III criteria for
* Child/Adolescent (Rasquin, 2006);
* 1 or more abdominal pain episodes per week over the past 8 weeks;
* Informed consent by study participant and at least one parent / legal guardian;
* Age 8-14 years;
* Pain severity at study entry must be at least 40 mm on a 100 mm VAS scale;
* Ability to understand and comply with the requirements of the trial;
* Stated availability throughout the study period.
Exclusion Criteria:
* Chronic illness;
* Surgery of Gastrointestinal tract;
* Any organic symptoms and/or clinical signs of disorder or disease other than FAP;
* Weight loss of 5% or more in body weight over the preceding 3 months;
* Any abnormal result of laboratory assays, also including screening for celiac disease, lactose intolerance;
* Exposure to any drug or medication (antidepressants, SSRIs, laxatives) in the past 3 months or regular use of this medication;
* Exposure to probiotics or antibiotics within 4 weeks prior to study; subjects can be included following a wash-out period of 4 weeks.
* Participation in other clinical trials in the past 3 months;
* Subjects with anemia;
* Subjects with special dietary needs
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
14 Years
Study:
NCT01498666
Study Brief:
Protocol Section:
NCT01498666