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OpenTrials
Completed

NCT Number: NCT01582659

Outpatient Treatment of Constipation in Children

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Line Modin, Kolding, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telephone Counseling

Other

2 planned telephone counseling sessions are conducted.

Other names: Telephone

Web access

Other

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

Other names: Web

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Line Modin

Other

Collaborators

  • University of Southern Denmark

Registry information

Official study title

Outpatient Treatment of Constipation in Children - a Randomized Interventions Study

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 20, 2012
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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