Clinical Trial

Co-supplementation With Bifidobacterium Longum W11 and Colopectin for Maintenance Therapy in Children With Functional Constipation

Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
Functional constipation is a common condition in children and often requires prolonged maintenance treatment with macrogol. This randomized, double-blind, placebo-controlled trial will evaluate whether co-supplementation with Bifidobacterium longum W11 and Colopectin can support maintenance therapy in children with functional constipation who are receiving macrogol and are candidates for weaning. Participants aged 2 to 6 years will be randomized to receive either the active supplementation or placebo once daily for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation. The study will assess persistence of constipation after macrogol discontinuation, as well as stool consistency, distress during evacuation, soiling episodes, and treatment compliance.
Trial Details
NCT Number NCT07536698
Lead Sponsor Liaquat University of Medical & Health Sciences
Collaborators: Università degli Studi dell'Insubria
Conditions Functional Constipation
Enrollment 100 participants
Start Date 2026-04-20
Primary Completion 2027-04-19 (estimated)
Study Completion 2027-05-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-17