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

NCT07536698 | Not Yet Recruiting DMC

• 1 other identifier: CET no. 5174/26/25.03.2026
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Functional Constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Stool Consistency (Bristol Stool Scale)

  Baseline, Week 4, and Week 8

• Presence of Distress During Evacuation (Caregiver-Reported Assessment)

  Baseline, Week 4, and Week 8

• Number of Soiling Episodes

  Baseline, Week 4, and Week 8

• Participant Compliance With Assigned Intervention (Caregiver-Reported Administration)

  Week 4

Study Arms (2)

Bifidobacterium longum W11 (Bowell®) + Colopectin + (Colopectin®)

EXPERIMENTAL

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®)

Placebo

PLACEBO COMPARATOR

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

Interventions

Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®) DIETARY_SUPPLEMENT

Combination of probiotic (Bifidobacterium longum W11) and prebiotic components (Colopectin) administered in sachet form once daily between meals in the afternoon.

Bifidobacterium longum W11 (Bowell®) + Colopectin + (Colopectin®)

Placebo OTHER

Placebo composed of corn starch, matched in appearance and administration schedule to the active intervention.

Placebo

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• Università degli Studi dell'Insubria: collaborator

Central Study Contacts

Francesco Valitutti, MD, PhD

CONTACT

+39 392 232 2182; Francesco.valitutti@unipg.it

Dr Amjad Khan, DPhil

CONTACT

amjadkhan@lumhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, parents or guardians, care providers, investigators, and outcome assessors will remain blinded to treatment allocation. Active treatment and placebo will be provided in sachet form and administered according to the same schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized in a 1:1 ratio to receive either co-supplementation with Bifidobacterium longum W11 and Colopectin or placebo in a parallel-group design. Treatment will be administered once daily for 4 weeks, followed by 4 weeks of follow-up after discontinuation.

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 17, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 19, 2027
• Study Completion (Estimated): May 17, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04