Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
239 participants
INTERVENTIONAL
2012-06-30
2014-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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No ekstra counseling
Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made.
No interventions assigned to this group
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.
Telephone counseling
2 planned telephone counseling sessions are conducted.
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.
Web access
Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 receiving drugs known to affect bowel function during a 2 month period before initiation.
2 Years
16 Years
ALL
No
Sponsors
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University of Southern Denmark
OTHER
Line Modin
OTHER
Responsible Party
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Line Modin
Medical doctor
Principal Investigators
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Marianne Jakobsen, MD, PhD
Role: STUDY_DIRECTOR
Kolding
Poul Erik Kofoed, MD. PHD
Role: STUDY_CHAIR
Kolding
Line Modin, MD
Role: PRINCIPAL_INVESTIGATOR
Kolding
Locations
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Line Modin
Kolding, , Denmark
Pediatric department, Kolding Hospital
Kolding, , Denmark
Countries
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References
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Modin L, Walsted AM, Rittig CS, Hansen AV, Jakobsen MS. Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):594-9. doi: 10.1097/MPG.0000000000000974.
Other Identifiers
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OutCon
Identifier Type: -
Identifier Source: org_study_id