A Phase 4 interventional study of Polyethylene glycol 4000 in Constipation, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Medical University of Warsaw · Phase 4, Interventional, and Treatment
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.
1,018 studies on the registry are indexed under Constipation; 140 are open to participants now.
This study's enrollment of 90 is above the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks
Drug: Polyethylene glycol 4000
Polyethylene glycol 4000: 0.7g/kg for 6 weeks
Drug: Polyethylene glycol 4000
Also known as: Forlax
therapeutic success (passing ≥ 3 stools per week, with no loosening of stool).
Time frame: the number and consistency of the stool will be recorded at 6th week of intervention
the number of stools delivered at 6th week of intervention
Time frame: the number of the stools will be recorded at the 6th week of intervention
the number of incontinence episodes
Time frame: the number of the incontinence episodes will be recorded at the 6th week of intervention
the number of painful defecation
Time frame: the number of painful defecation will be recorded at the 6th week of intervention
the number of episodes of abdominal pain
Time frame: 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
Time frame: 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
Time frame: the number and the character of the side effects will be recorded for six weeks of intervention
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw