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 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT06310733
Eligibility Criteria:
Inclusion Criteria:
* Children, aged 6-15 years old, with a diagnosis of IBS or FAP, according to the Rome IV diagnostic criteria. The diagnosis of IBS or FAP was based on a clinical interview performed by pediatric gastroenterologist.
For healthy controls: non-obese children, aged 6-15 years old, without any gastrointestinal symptoms at the time of recruitment.
Exclusion Criteria:
* Children who
1. had any chronic diseases, including neurobehavioral disorders
2. received treatment with antibiotics/probiotics in the previous 2 months
3. received medication that affects gastrointestinal motility in the previous 1 week
4. had a pain history suggestive of functional dyspepsia/aerophagia/abdominal migraine/functional constipation
5. exhibited growth failure
6. had gastrointestinal obstructions/stricture
7. displayed alarming signs of organic condition
8. had previous abdominal surgery
9. had abnormal baseline test results as part of their standard work-up (e.g. complete blood counts; erythrocyte sedimentation rate; liver-pancreas-kidney function tests; stool examination for occult blood, ova, and parasites; fecal calprotectin; urinalysis; abdominal ultrasound; 13C-urea breath test; gastric emptying study, if any)
10. had family history of peptic ulcer disease or inflammatory bowel disease
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
15 Years
Study:
NCT06310733
Study Brief:
Protocol Section:
NCT06310733