Constipation
Conditions
Keywords
constipation, children, polyethylene glycol
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.
Interventions
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 stools delivered at 6th week of intervention | the number of the stools 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 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 |
| the number of episodes of abdominal pain | the number of the episodes of abdominal pain will be recorded at the 6th week of intervention | — |
Countries
Poland
Outcome results
None listed