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NOT YET RECRUITING
NCT07536698
NA

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

Sponsor: Liaquat University of Medical & Health Sciences

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.

Official title: Efficacy of Co-supplementation With Bifidobacterium Longum W11 and Colopectin in the Maintenance Therapy of Children With Functional Constipation: A Randomized Double-Blind Placebo-Controlled Trial

Key Details

Gender

All

Age Range

2 Years - 6 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-04-20

Completion Date

2027-05-17

Last Updated

2026-04-17

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®)

Combination of probiotic (Bifidobacterium longum W11) and prebiotic components (Colopectin) administered in sachet form once daily between meals in the afternoon.

OTHER

Placebo

Placebo composed of corn starch, matched in appearance and administration schedule to the active intervention.