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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-6
SponsorLiaquat University of Medical & Health Sciences

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

100 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Liaquat University of Medical & Health Sciences

Lead sponsor

Università degli Studi dell'Insubria

Collaborator