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

A new clinical trial registration has been added to the NIH ClinicalTrials.gov registry. The study will evaluate whether co-supplementation with the probiotic Bifidobacterium longum W11 (Bowell®) and the prebiotic Colopectin® can support maintenance therapy in young 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 active supplementation or placebo once daily for 4 weeks, followed by 4 weeks of follow-up after discontinuation.

For clinical investigators and healthcare providers, this trial represents a potential alternative maintenance strategy for pediatric functional constipation management. The study will assess multiple clinical endpoints including persistence of constipation after macrogol discontinuation, stool consistency, distress during evacuation, soiling episodes, and treatment compliance. Sponsors and clinical sites preparing to conduct this trial should ensure compliance with applicable FDA clinical trial regulations and IRB oversight requirements.