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Completed

NCT Number: NCT01875744

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.

Completed

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dpt of Pediatrics The Medical University of Warsaw

Warsaw, 01-184, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Polyethylene glycol 4000

Drug

Other names: Forlax

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. the number of incontinence episodes

    Time frame: the number of the incontinence episodes will be recorded at the 6th week of intervention

  3. the number of painful defecation

    Time frame: the number of painful defecation will be recorded at the 6th week of intervention

  4. 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

  5. the number of patients needed laxatives during treatment

    Time frame: the number patiens needed laxatives will be recorded for six weeks of intervention

  6. side effects

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 12, 2013
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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