Polyethylene Glycol for Childhood Constipation

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Constipation

Treatments: Drug: Polyethylene glycol 4000

Study type: Interventional

Funder types: Other

Identifiers

NCT01875744

2/2013 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

90 participants in 2 patient groups

Polyethylene glycol small dose

Experimental group

Description:

Polyethylene glycol 4000: 0.3 g/kg/day for 6 weeks

Treatment:

Drug: Polyethylene glycol 4000

Polyethylene glycol high dose

Active Comparator group

Description:

Polyethylene glycol 4000: 0.7g/kg for 6 weeks

Treatment:

Drug: Polyethylene glycol 4000