Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

age 1 - 18 age
functional constipation according to the Rome III Criteria
consent of parents or guardians of the child to participate and study
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 Criterias

organic cause constipation (including surgeries within the lower GI tract)
organic cause constipation (including surgeries within the lower GI tract)

Summary

Conditions
Constipation
Type
Interventional
Phase
Phase 4
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 1 years and 18 years
Gender
Both males and females

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 ...

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.

Inclusion Criterias

age 1 - 18 age
functional constipation according to the Rome III Criteria
consent of parents or guardians of the child to participate and study
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 Criterias

organic cause constipation (including surgeries within the lower GI tract)
organic cause constipation (including surgeries within the lower GI tract)

Locations

Warsaw, 01-184
Warsaw, 01-184

Tracking Information

NCT #
NCT01875744
Collaborators
Not Provided
Investigators
  • Principal Investigator: Andrea Horvath, MD Medical University of Warsaw
  • Andrea Horvath, MD Medical University of Warsaw