Clinical trial NCT01875744: Polyethylene Glycol for Childhood Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Constipation
Keywords: constipation
children
polyethylene glycol
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 84
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: therapeutic success (passing ≥ 3 stools per week, with no loosening of stool).
timeFrame: the number and consistency of the stool will be recorded at 6th week of intervention
Secondary outcomes:
measure: the number of stools delivered at 6th week of intervention
timeFrame: the number of the stools will be recorded at the 6th week of intervention
measure: the number of incontinence episodes
timeFrame: the number of the incontinence episodes will be recorded at the 6th week of intervention
measure: the number of painful defecation
timeFrame: the number of painful defecation will be recorded at the 6th week of intervention
measure: the number of episodes of abdominal pain
timeFrame: the number of the episodes of abdominal pain will be recorded at the 6th week of intervention
measure: the number of patients needed laxatives during treatment
timeFrame: the number patiens needed laxatives will be recorded for six weeks of intervention
measure: side effects
timeFrame: the number and the character of the side effects will be recorded for six weeks of intervention
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Dpt of Pediatrics The Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Andrea Horvath, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.