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.
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
Children with intestinal meteorism or flatulence
Children diagnosed with organic constipation
History of previous abdominal surgery
Children with frailty or disabilities
Parallel
Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®)
Dietary supplementCombination of probiotic (Bifidobacterium longum W11) and prebiotic components (Colopectin) administered in sachet form once daily between meals in the afternoon.
Placebo
Other interventionPlacebo composed of corn starch, matched in appearance and administration schedule to the active intervention.
Persistence of Constipation After Discontinuation of Macrogol Therapy
Persistence of constipation defined as 2 or fewer bowel movements per week after discontinuation of macrogol therapy.
Change in Stool Consistency (Bristol Stool Scale)
Change in stool consistency assessed using the Bristol Stool Scale between baseline (T0), Week 4 (T1), and Week 8 (T2).
Presence of Distress During Evacuation (Caregiver-Reported Assessment)
Assessment of presence or absence of distress during defecation based on caregiver or parent report recorded during clinical evaluation.
Number of Soiling Episodes
Number of episodes of fecal soiling during the study period.
Participant Compliance With Assigned Intervention (Caregiver-Reported Administration)
Assessment of participant compliance with the assigned intervention based on caregiver or parent report of administration of the study product during the treatment period.
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Liaquat University of Medical & Health Sciences
Lead sponsor
Università degli Studi dell'Insubria
Collaborator
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