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:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-24 @ 7:01 PM
NCT ID:
NCT06924957
Eligibility Criteria:
Inclusion criteria - the study group:
* age from 5 to 18 years old
* functional constipation diagnosed on the basis of Rome IV criteria
* parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent
Inclusion criteria - the control group:
* age from 5 to 18 years old
* no lower gastrointestinal symptoms
* parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent
Exclusion criteria - the study group and the control group:
* undergone surgeries due to congenital anomalies in the lower gastrointestinal tract
* inflammatory bowel diseases or inflammation of the large intestine with a different aetiology
* anal fissure, inflammation of the anal area or other conditions which, in the opinion of the researcher, could affect the functioning of the distal gastrointestinal tract
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT06924957
Study Brief:
Protocol Section:
NCT06924957