About this trial
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.
Eligibility criteria
Qualifiers
Children aged 2 to 6 years
Diagnosis of functional constipation
Receiving maintenance therapy with macrogol for at least 3 months
Candidates for weaning from macrogol therapy
Disqualifiers
Children with intestinal meteorism or flatulence
Children diagnosed with organic constipation
History of previous abdominal surgery
Children with frailty or disabilities
Trial design
Treatments tested in this trial
- Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®)
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Liaquat University of Medical & Health Sciences
Lead sponsor
Università degli Studi dell'Insubria
Collaborator