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 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT04624334
Eligibility Criteria:
Inclusion Criteria:
* All participants:
* Age ≤ 11 years for babies and children
* Age ≥ 18 years for adults.
Patients
* For babies/children:
* suffering from surgically untreated HSCR as determined by a rectal biopsy, or
* suspected of HSCR, for which a rectal biopsy is planned
* For adults: Suffering from a (suspected,) surgically untreated functional colonic motility disorder (such as slow-transit constipation, idiopathic/therapy resistant constipation of the colon), as diagnosed previously or will be diagnosed in the near future using the gold standard method.
Exclusion criteria:
* All participants:
* For adults: BMI \> 27 kg/m2
* For babies/children: weight for length \> 2.5 standard deviations of WHO Child Growth Standard
* Pregnancy
* Diabetes
* Any food intolerance
* Presence of an intestinal stoma
* Use of continuous tube feeding
* Healthy controls:
* The presence of any known gastro-intestinal conditions
* Use of laxatives in the past two years
* Participants with (suspected) motility disorder:
* (Part of) colon removed
* Inflammatory bowel disease
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT04624334
Study Brief:
Protocol Section:
NCT04624334