Overview

Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years.

Status:
Unknown status

Trial end date:
2018-05-01

Target enrollment:

Participant gender:

Summary

Assessment of efficacy of Dicopeg Junior, compared to lactulose, in the treatment of functional constipation in children aged 6 months to 6 years. The basis of assessment is to compare the number of commissioned stools (more than three stools per week) and stool consistency according to the scale of Bristol, in children taking Dicopeg Junior and children treated with lactulose. Childrens who meet the inclusion criteria will be randomized to one of two groups, in which the treatment will be as follows for 12 weeks: 1. The first group - Dicopeg Junior (max. in 2 doses) in a dose of: - weight up to 8 kg - 1 sachet per day - weight 8 - 12 kg - 2 sachets a day - weight 12 - 20 kg - 3 sachets a day - weight> 20 kg - 4 sachets per day, 2. The second group - Lactulose at 2 ml / kg / day (in two doses). Preparations: Dicopeg Junior and Lactulose will be administered orally for the duration of the study (12 weeks).

Phase:

Phase 4

Details

Lead Sponsor:

Children's Memorial Health Institute, Poland

Collaborators:

Medical University of Bialystok
University of Rzeszow

Treatments:

Lactulose