Polyethylene Glycol for Childhood Constipation

Study Overview
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Brief Summary
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Background: Aim: Clinical evaluation of the effectiveness of two different polyethylene glycol doses for the maintenance treatment of functional constipation in children. Study design: Randomized, open-label trial. Randomized, double-blind, placebo controlled trial.

Detailed Description
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Children will be randomly assigned into 2 groups receiving polyethylene glycol 4000 (Forlax) with an initial dose of either 0.3g/kg, or 0.7 g / kg. In case of ineffectiveness the dose of medication will be increased every two weeks with 0.2 g/kg. The indication for the increase in dose will be less than 3 bowel movements per week. For children with diarrhea defined as more than 3 loose stools for minimum 2 days or/and severe abdominal pain the macrogol dose of will be reduced every two weeks by 0.2 g/kg. The intervention will last 6 weeks.

Conditions
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Constipation

Intervention / Treatment
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* Drug: Polyethylene glycol 4000


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 1 - 18 age functional constipation according to the Rome III Criteria consent of parents or guardians of the child to participate and study Exclusion Criteria: organic cause constipation (including surgeries within the lower GI tract)

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Polyethylene glycol small dose<br>Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks | Drug: Polyethylene glycol 4000<br> <br> * Other names: Forlax;|
| Active Comparator: Polyethylene glycol high dose<br>Polyethylene glycol 4000: 0.7g/kg for 6 weeks | Drug: Polyethylene glycol 4000<br> <br> * Other names: Forlax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| therapeutic success (passing ≥ 3 stools per week, with no loosening of stool). |  | the number and consistency of the stool will be recorded at 6th week of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of stools delivered at 6th week of intervention |  | the number of the stools will be recorded at the 6th week of intervention | 
| the number of incontinence episodes |  | the number of the incontinence episodes will be recorded at the 6th week of intervention | 
| the number of painful defecation |  | the number of painful defecation will be recorded at the 6th week of intervention | 
| the number of episodes of abdominal pain |  | the number of the episodes of abdominal pain will be recorded at the 6th week of intervention | 
| the number of patients needed laxatives during treatment |  | the number patiens needed laxatives will be recorded for six weeks of intervention | 
| side effects | the number and character of the sides effects will be recorded by the patient at the diary during the 6 weeks of the intervention | the number and the character of the side effects will be recorded for six weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, children, polyethylene glycol