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Outpatient Treatment of Constipation in Children

Outpatient Treatment of Constipation in Children - a Randomized Interventions Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01582659
Enrollment
239
Registered
2012-04-20
Start date
2012-06-30
Completion date
2014-10-31
Last updated
2014-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

constipation, children, outpatient

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.

Interventions

OTHERTelephone counseling

2 planned telephone counseling sessions are conducted.

Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.

Sponsors

University of Southern Denmark
CollaboratorOTHER
Line Modin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Treatment recovery1 yearRecovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.

Secondary

MeasureTime frameDescription
Usage of laxative.1 yearAmount of laxative used during the study periode.
Telephone contacts1 yearNumber of telephone contacts during the study periode, both planned and unplanned contacts will be noted.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026