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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT05570318
Eligibility Criteria:
Inclusion Criteria:
* age 4-14 years
* medical history with fecal incontinence \>1/week on a non-neurogenic but retentive basis (fulfills ROME-IV-criteria)
* non-responsive after min. 2 months treatment with polyethylene glycols and behavioral interventions (set times for toilet use)
Exclusion Criteria:
* Hirschsprungs disease
* anorectal malformations
* use of medications known to cause constipation (eg. anticholinergics)
* former use of low or high volume TAI or enemas
Contraindications for use of MiniGo-irrigation device:
* known stenosis of the rectum or intestinal tract
* colorectal cancer prior to surgical removal
* acute inflammatory bowel disease
* acute diverticulitis
* within 3 months of surgical procedures in the rectum or intestinal tract
* within 4 weeks of endoscopic polypectomy
* ischemic colitis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
14 Years
Study:
NCT05570318
Study Brief:
Protocol Section:
NCT05570318