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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Functional Constipation
• Intervention / Treatment: Dietary supplement: Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®); Other: Placebo

Detailed Description

Functional constipation is one of the most common gastrointestinal disorders in childhood and is frequently associated with painful or infrequent defecation, stool retention, and reduced quality of life. In many children, maintenance treatment with macrogol is required for prolonged periods, and gradual weaning may be clinically challenging. Therefore, supportive dietary or microbiota-targeted strategies that may facilitate maintenance management and discontinuation of macrogol are of clinical interest.

Bifidobacterium longum W11 is a probiotic strain with potential effects on intestinal function and motility, while Colopectin contains prebiotic and fiber-related components that may help support bowel regularity. The combination is being investigated as a co-supplementation strategy in children with functional constipation during the maintenance phase of treatment.

This study is a randomized, double-blind, placebo-controlled, parallel-group trial in children aged 2 to 6 years with functional constipation who have been receiving maintenance-dose macrogol for at least 3 months and are candidates for treatment weaning. A total of 100 participants will be randomized in a 1:1 ratio to receive either Bifidobacterium longum W11 (Bowell®) plus Colopectin (Colopectin®) or placebo, administered once daily between meals in the afternoon for 4 weeks. After the treatment period, supplementation will be discontinued and participants will be monitored for an additional 4 weeks.

Clinical assessments will be performed at baseline (T0), at Week 4 (T1), and at Week 8 (T2). The primary endpoint is persistence of constipation, defined as 2 or fewer bowel movements per week, after discontinuation of macrogol therapy. Secondary endpoints include changes in stool consistency assessed using the Bristol Stool Scale, presence or absence of distress during evacuation, number of soiling episodes, and treatment compliance.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Amjad Khan, DPhil; Email: amjadkhan@lumhs.edu.pk
• Study Contact Backup: Name: Francesco Valitutti, MD, PhD; Phone Number: +39 392 232 2182; Email: Francesco.valitutti@unipg.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Children with intestinal meteorism or flatulence
• Children diagnosed with organic constipation
• History of previous abdominal surgery
• Children with frailty or disabilities
• Presence of other organ diseases or syndromes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bifidobacterium longum W11 (Bowell®) + Colopectin + (Colopectin®); Participants will receive co-supplementation with Bifidobacterium longum W11 (Bowell®) and Colopectin (Colopectin®) administered once daily between meals in the afternoon for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation.	Dietary supplement: 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 Comparator: Placebo; Participants will receive placebo (corn starch) formulated in sachets, administered once daily between meals in the afternoon for 4 weeks, followed by 4 weeks of follow-up after treatment discontinuation.	Other: Placebo; Placebo composed of corn starch, matched in appearance and administration schedule to the active intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline, Week 4, and Week 8
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.	Baseline, Week 4, and Week 8
Number of Soiling Episodes	Number of episodes of fecal soiling during the study period.	Baseline, Week 4, and Week 8
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.	Week 4

Collaborators and Investigators

• Sponsor: Liaquat University of Medical & Health Sciences
• Collaborators: Università degli Studi dell'Insubria

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): April 19, 2027
• Study Completion (Estimated): May 17, 2027

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CET no. 5174/26/25.03.2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No