Effect of Probiotic on Gut Microbiota in Young Children With Functional Constipation

This study was a 28-day, open-label, randomized controlled trial involving infants and toddlers diagnosed with functional constipation. Participants were randomized to receive either Bifidobacterium longum subsp. longum Dipro-X, lactulose, or a combination of both. The primary clinical outcomes assessed were bowel movement frequency, stool consistency, and defecation difficulty. To investigate potential mechanisms, stool samples were collected pre- and post-intervention for metagenomics sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.

NCT Number	NCT07360535
Lead Sponsor	Min-Tze LIONG Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Conditions	Functional Constipation in Children
Enrollment	84 participants
Start Date	2020-06-10
Primary Completion	2026-02-28 (estimated)
Study Completion	2026-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-04-07