Polyethylene Glycol for Childhood Constipation

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: Polyethylene glycol 4000

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 Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-184
    • Dpt of Pediatrics The Medical University of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Polyethylene glycol small dose; Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks	Drug: Polyethylene glycol 4000; Other Names: Forlax
Active Comparator: Polyethylene glycol high dose; Polyethylene glycol 4000: 0.7g/kg for 6 weeks	Drug: Polyethylene glycol 4000; Other Names: Forlax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Andrea Horvath, MD, Medical University of Warsaw

Publications and helpful links

General Publications

• Dziechciarz P, Horvath A, Szajewska H. Polyethylene glycol 4000 for treatment of functional constipation in children. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):65-8. doi: 10.1097/MPG.0000000000000543.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 30, 2013

Study Registration Dates

• First Submitted: June 6, 2013
• First Submitted That Met QC Criteria: June 9, 2013
• First Posted (Estimated): June 12, 2013

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: children; polyethylene glycol; constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 2/2013 (Other Grant/Funding Number: The Medical University of Warsaw)