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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT04614935
Eligibility Criteria:
Inclusion Criteria:
* Have been potty-trained for stool at some point
* Chief complaint constipation or encopresis
* Meets Rome IV criteria for functional constipation
Exclusion Criteria:
* Preexisting diagnoses of autism, cerebral palsy, developmental delay, and/or thyroid disease
* Prior gastrointestinal surgery
* Presence of "red flag" symptoms for organic etiology:
* Passage of meconium \>48 hours after birth in a term newborn
* Family history of Hirschsprung's Disease
* "Ribbon" stools
* Blood in stools (in absence of anal fissure)
* Coexisting diagnosis of malnutrition, bilious vomiting, abnormal anal positioning, absent anal reflex, decreased lower extremity strength/tone, sacral dimple, and/or tuft of hair on spine
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
8 Years
Study:
NCT04614935
Study Brief:
Protocol Section:
NCT04614935