Co-supplementation With Bifidobacterium Longum W11 and Colopectin for Maintenance Therapy in Children With Functional Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bifidobacterium longum W11 (Bowell®) + Colopectin (Colopectin®), Placebo.
- Who it may be relevant to
- Registry conditions: Functional Constipation. Basic parameters: 2 years — 6 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
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.
Interventions
- 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. - Other Placebo
Placebo composed of corn starch, matched in appearance and administration schedule to the active intervention.
Primary outcome measures
- Persistence of Constipation After Discontinuation of Macrogol Therapy [Time frame: Week 8]
Secondary outcome measures (4)
- Change in Stool Consistency (Bristol Stool Scale) [Time frame: Baseline, Week 4, and Week 8]
- Presence of Distress During Evacuation (Caregiver-Reported Assessment) [Time frame: Baseline, Week 4, and Week 8]
- Number of Soiling Episodes [Time frame: Baseline, Week 4, and Week 8]
- Participant Compliance With Assigned Intervention (Caregiver-Reported Administration) [Time frame: Week 4]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07536698 · CET no. 5174/26/25.03.2026