Outpatient Treatment of Constipation in Children

Constipation Clinical Trial

Official title:

Outpatient Treatment of Constipation in Children - a Randomized Interventions Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582659
• Other study ID #: OutCon
• Status: Completed
• Phase: N/A
• First received: March 27, 2012
• Last updated: December 4, 2014
• Start date: June 2012
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Other:
• Telephone counseling
2 planned telephone counseling sessions are conducted.
• Web access
Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.

Locations

Country	Name	City	State
Denmark	Line Modin	Kolding
Denmark	Pediatric department, Kolding Hospital	Kolding

Sponsors (2)

Lead Sponsor	Collaborator
Line Modin	University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment recovery	Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.	1 year	No
Secondary	Usage of laxative.	Amount of laxative used during the study periode.	1 year	No
Secondary	Telephone contacts	Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted.	1 year	No