Polyethylene Glycol for Childhood Constipation

Phase 4

• Conditions: Constipation
• Interventions: Drug: Polyethylene glycol 4000

• Registration Number: NCT01875744
• Lead Sponsor: Medical University of Warsaw

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-09
• Study First Posted: 2013-06-12
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Last Update Submitted: 2013-11-01
• Last Update Posted: 2013-11-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Polyethylene glycol small dose	Polyethylene glycol 4000	Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks
Polyethylene glycol high dose	Polyethylene glycol 4000	Polyethylene glycol 4000: 0.7g/kg for 6 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 stools delivered at 6th week of intervention	the number of the stools 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 the character of the side effects will be recorded for six weeks of intervention	the number and character of the sides effects will be recorded by the patient at the diary during the 6 weeks of the intervention

Trial Locations

Locations (1)

Dpt of Pediatrics The Medical University of Warsaw; 🇵🇱 Warsaw, Poland