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Outpatient Treatment of Constipation in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01582659
Recruitment Status : Completed
First Posted : April 20, 2012
Last Update Posted : December 5, 2014
University of Southern Denmark
Information provided by (Responsible Party):
Line Modin, Vejle Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Constipation Other: Telephone counseling Other: Web access Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Treatment of Constipation in Children - a Randomized Interventions Study
Study Start Date : June 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Treatment recovery [ Time Frame: 1 year ]
    Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.

Secondary Outcome Measures :
  1. Usage of laxative. [ Time Frame: 1 year ]
    Amount of laxative used during the study periode.

  2. Telephone contacts [ Time Frame: 1 year ]
    Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01582659

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Line Modin, Medical doctor, Vejle Hospital Identifier: NCT01582659    
Other Study ID Numbers: OutCon
First Posted: April 20, 2012    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Line Modin, Vejle Hospital:
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms