Do Most Children with Functional Constipation Meet the Commonly Used Clinical Trial Endpoints?

ABSTRACT:

Background/objectives

Functional constipation (FC) is diagnosed using the Rome IV criteria, which require at least two of seven symptoms for diagnosis. Clinical trials evaluating FC treatments commonly use bowel movement frequency, stool consistency, and fecal incontinence as primary endpoints. However, there is limited data on whether these endpoints accurately represent the symptom distribution in children with FC. This study assessed the frequency of each criterion in a large children's community sample to determine whether commonly used clinical trial endpoints accurately reflect symptom distribution.

Methods

A cross-sectional study of school children aged 8-18 years was conducted across seven Colombian cities. Participants completed the Pediatric Gastrointestinal Sympto

SUBMITTER: Arrizabalo S 

PROVIDER: S-EPMC11854065 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature