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 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT04710433
Eligibility Criteria:
Inclusion Criteria:
* age between 2-17 years
* informed consent
* chronic constipation according to the ROME IV criteria for more than 3 months with or without encopresis/soiling
* refractory to conventional treatment in a sufficient application (training for bowel movements, lifestyle changes, pelvic floor training)
* exclusion of metabolic, inflammatory and hormonal causes for chronic constipation (such as e.g., celiac disease, cystic fibrosis, hypothyroidism)
* in cases of underlying Hirschsprung's disease: confirmation of diagnosis via rectal biopsies
* in cases of anorectal malformation: post-surgical status
Exclusion Criteria:
* metabolic, inflammatory and hormonal causes for chronic constipation with further therapeutic options
* toxic megacolon or further emergencies, which must be treated surgically
* fractures or substantial differences in the sacral anatomy
* inflammatory bowel disorders
* rectal prolapse
* neuronal malignancies under medical and radiation therapy
* seizures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT04710433
Study Brief:
Protocol Section:
NCT04710433