Polyethylene Glycol for Childhood Constipation

Medical University of Warsaw90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Enrollment

Conditions

Constipation

Interventions

Polyethylene glycol 4000DRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Dpt of Pediatrics The Medical University of Warsaw

Warsaw, Poland

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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