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Co-supplementation With Bifidobacterium Longum W11 and Colopectin for Maintenance Therapy in Children With Functional Constipation
Sponsor: Liaquat University of Medical & Health Sciences
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
Conditions
Interventions
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.
Placebo
Placebo composed of corn starch, matched in appearance and administration schedule to the active intervention.