Outpatient Treatment of Constipation in Children

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Line Modin, Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01582659
First received: March 27, 2012
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Constipation
Other: Telephone counseling
Other: Web access

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 225
Study Start Date: June 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582659

Locations
Denmark
Line Modin
Kolding, Denmark, 6000
Pediatric department, Kolding Hospital
Kolding, Denmark, 6000
Sponsors and Collaborators
Line Modin
University of Southern Denmark
Investigators
Study Director: Marianne Jakobsen, MD, PhD Kolding
Study Chair: Poul Erik Kofoed, MD. PHD Kolding
Principal Investigator: Line Modin, MD Kolding
  More Information

No publications provided

Responsible Party: Line Modin, Medical doctor, Vejle Hospital
ClinicalTrials.gov Identifier: NCT01582659     History of Changes
Other Study ID Numbers: OutCon
Study First Received: March 27, 2012
Last Updated: July 3, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Vejle Hospital:
constipation
children
outpatient

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014