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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT01985867
Eligibility Criteria:
Inclusion Criteria:
* Children below 5 years of age
* Functional constipation according to Rome III criteria i.e. 1 month of at least 2 of the following:
* Two or fewer defecations per week
* At least 1 episode per week of incontinence after the acquisition of toileting skills
* History of excessive stool retention
* History of painful or hard bowel movements
* Presence of a large fecal mass in the rectum
* History of large- diameter stools that may obstruct the toilet
Exclusion Criteria:
* Irritable bowel syndrome
* Mental retardation
* Endocrine disease (e.g. hypothyroidism)
* Organic cause of constipation (e.g. Hirschsprung disease)
* Spinal anomalies
* Anatomic defects of the anorectum
* History of previous gastrointestinal surgery
* Functional nonretentive fecal incontinence
* Use of drugs that influence gastrointestinal motility
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
5 Years
Study:
NCT01985867
Study Brief:
Protocol Section:
NCT01985867