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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07392203
Eligibility Criteria:
InclusioChildren ≥3 and ≤16 years with Fecal incontinence (≥1 episode/week) due to corrected anorectal malformation (ARM), Hirschsprung disease after pull-through, perineal trauma, spinal anomalies/neurogenic bowel, or functional constipation with overflow incontinence.
Ability to participate in a structured bowel-management regimen at home.
Caregiver availability for training and daily administration. n Criteria:
\- Age \<3 years. symptomatic anal stricture, or other anatomic issues requiring surgical correction before bowel management.
Current enterocolitis, Active proctitis, painful fissure with bleeding, or severe perianal dermatitis precluding safe catheterization.
Chronic kidney disease, unstable cardiac disease, or known electrolyte imbalance.
Hypersensitivity/intolerance to glycerin; prior severe reaction to enemas. Stoma in situ or ACE dependence (separate pathway).
Exclusion Criteria:
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
16 Years
Study:
NCT07392203
Study Brief:
Protocol Section:
NCT07392203