Constipation Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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