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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Memorial Health Institute, Poland
• Collaborators: Medical University of Bialystok; University of Rzeszow
• Treatments: Lactulose

Criteria

Inclusion Criteria:

1. Children aged 6 months - 6 years

2. Diagnosis of functional constipation according to the Rome III criteria

3. Patients newly recognized or ineffectively treated

4. Parental consent for their child's participation in the study and the way they are treatment for the duration of the study

Exclusion Criteria:

1. Well-known organic cause constipation (eg. an underactive thyroid, Hirschprung disease, cystic fibrosis).

2. Anatomical abnormality of the digestive tract.

3. Status after gastrointestinal surgery

4. Parents disagree to participate in the study

5. Intolerance of lactulose or polyethylene glycols in an interview

6. Comorbidities that may significantly affect the treatment outcome: food allergy, celiac disease, CNS disease, lactose intolerance or other disaccharide bacterial overgrowth