Functional Constipation
Conditions
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.
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_SUPPLEMENTBifidobacterium 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.
OTHERPlacebo
Placebo composed of corn starch, matched in appearance and administration schedule to the active intervention.
Sponsors
Liaquat University of Medical & Health Sciences
Università degli Studi dell'Insubria
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Persistence of Constipation After Discontinuation of Macrogol Therapy | Week 8 | Persistence of constipation defined as 2 or fewer bowel movements per week after discontinuation of macrogol therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stool Consistency (Bristol Stool Scale) | Baseline, Week 4, and Week 8 | 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) | Baseline, Week 4, and Week 8 | Assessment of presence or absence of distress during defecation based on caregiver or parent report recorded during clinical evaluation. |
| Number of Soiling Episodes | Baseline, Week 4, and Week 8 | Number of episodes of fecal soiling during the study period. |
| Participant Compliance With Assigned Intervention (Caregiver-Reported Administration) | Week 4 | Assessment of participant compliance with the assigned intervention based on caregiver or parent report of administration of the study product during the treatment period. |
Contacts
CONTACTFrancesco Valitutti, MD, PhD
CONTACTDr Amjad Khan, DPhil
Outcome results
None listed