Outpatient Treatment of Constipation in Children

Study Overview
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Brief Summary
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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.

Official Title
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Outpatient Treatment of Constipation in Children - a Randomized Interventions Study

Conditions
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Constipation

Intervention / Treatment
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* Other: Telephone counseling
* Other: Web access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between 2 and 16 years and referral to our out patient clinic with either constipation or fecal incontinence. Patients must fulfill the Rome III criteria of constipation, which mean they must have at least 2 of the following characteristics: fewer than 3 bowel movements weekly, more than 1 episode of fecal incontinence weekly, large stools in the rectum by digital rectal examination or palpable on abdominal examination, occasional passing of large stools, display of retentive posturing and withholding behavior, and painful defecation. Exclusion Criteria: Children with known organic causes of constipation, including Hirschsprungs disease, spinal and anal congenital abnormalities, previous surgery on the colon, inflammatory bowel disease, allergy and metabolic or endocrine diseases. Children receiving drugs known to affect bowel function during a 2 month period before initiation.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No ekstra counseling<br>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<br>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<br>* 2 planned telephone counseling sessions are conducted.<br>* Other names: Telephone;|
| Active Comparator: Web access<br>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<br>* Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.<br>* Other names: Web;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment recovery | Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of laxative. | Amount of laxative used during the study periode. | 1 year | 
| Telephone contacts | Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, children, outpatient