Outpatient Treatment of Constipation in Children
Constipation is a condition often seen in children. Constipation is often associated with impaired quality of life of the child and of great concern among parents. Despite the fact that both diagnosis and treatment is a simple task, it is often seen that the treatment fails, and many children are referred to a pediatric ward for specialized treatment.
There is currently little research on the subject and treatment is therefore based on expert knowledge rather than scientific research.
The study objective is to identify the most effective and least stressful treatment of children with constipation for both families and the health care system.
The following will be tested:
Does treatment of constipation in children require specialized knowledge and extensive resources or can the treatment be simplified?
The results from this study are expected to form the basis for a evidence based treatment of children with constipation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Outpatient Treatment of Constipation in Children - a Randomized Interventions Study|
- Treatment recovery [ Time Frame: 1 year ] [ Designated as safety issue: No ]Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.
- Usage of laxative. [ Time Frame: 1 year ] [ Designated as safety issue: No ]Amount of laxative used during the study periode.
- Telephone contacts [ Time Frame: 1 year ] [ Designated as safety issue: No ]Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted.
|Study Start Date:||June 2012|
|Study Completion Date:||October 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
No Intervention: No ekstra counseling
Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made.
Active Comparator: 2 counseling sessions
Standardized information about childhood constipation is given and the child receives PEG 3350. 2 additional follow up appointments by telephone are made.
Other: Telephone counseling
2 planned telephone counseling sessions are conducted.
Other Name: Telephone
Active Comparator: Web access
Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made but the family are given access to a website with information about childhood constipation.
Other: Web access
Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.
Other Name: Web
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582659
|Kolding, Denmark, 6000|
|Pediatric department, Kolding Hospital|
|Kolding, Denmark, 6000|
|Study Director:||Marianne Jakobsen, MD, PhD||Kolding|
|Study Chair:||Poul Erik Kofoed, MD. PHD||Kolding|
|Principal Investigator:||Line Modin, MD||Kolding|