Maintenance Treatment for Children With Constipation

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: NCT01566409
Recruitment Status : Completed
First Posted : March 29, 2012
Results First Posted : September 28, 2016
Last Update Posted : September 28, 2016
University of Southern Denmark
Kolding Sygehus
Information provided by (Responsible Party):
Line Modin, Vejle Hospital

March 27, 2012
March 29, 2012
August 4, 2016
September 28, 2016
September 28, 2016
September 2013
April 2015   (Final data collection date for primary outcome measure)
Treatment Recovery [ Time Frame: ½ year ]
Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.
Treatment Recovery [ Time Frame: 1 year ]
Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.
Complete list of historical versions of study NCT01566409 on Archive Site
Usage of Laxative [ Time Frame: ½ year ]
  • Usage of laksative [ Time Frame: 1 year ]
  • Measurement of rectal diameter [ Time Frame: 3 months ]
    Transabdominal ultrasound with measurement of the rectal diameter will be performed 6 times within the first 3 months of the study to evaluate changes of the rectal diameter during mainenance treatment.
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Maintenance Treatment for Children With Constipation
Maintenance Treatment With Polyethylene Glycol 3350 for Children With Constipation. A Randomized, Placebocontrolled Intervention Study

Constipation is a common problem among children. The majority of children suffering from constipation have no underlying disease. Although constipation has no basis in underlying disease, it often leads to a reduced quality of life of children who are on par with or worse than for children suffering from serious diseases such as cardiovascular and rheumatic diseases.

Despite the high frequency of constipation among children, little is known about the causes and treatment of constipation.

Treatment consists of symptomatic treatment with various laxatives. Movicol and Movicol junior has proven very effective and are therefore widely used in children as disimpaction and maintenance treatment. There is currently no research to prove the need for and length of maintenance treatment with laxative medications in children.

The purpose is to examining the effectiveness of maintenance treatment with Movicol. Additional til study will examine how the anal diameter change during a course of treatment and the degree to which it can be used as an indicator of treatment efficacy.

The study will test the following:

• What is the effect of maintenance treatment with PEG compared to placebo?

The results from this study are expected to form the basis for an evidence-based approach to the use of maintenance therapy and the use of ultrasound of the rectum in children with constipation.

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Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Drug: Polyethylene glycol 3350
    Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
    Other Names:
    • Movicol
    • Movicol junior
    • Moxalole
    • Lacrofarm
  • Other: Placebo
    Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
  • Active Comparator: Active maintenance treatment
    Intervention: Drug: Polyethylene glycol 3350
  • Placebo Comparator: Placebo maintenance treatment
    Intervention: Other: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2015
April 2015   (Final data collection date for primary outcome measure)

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 Hirsprung 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.
  • The healthy control group consists of children with no history of constipation (Rome III), urinary incontinence, urinary tract infections, fecal incontinence, laxative use or any other disease affecting the digestive system.
  • Children receiving medications known to affect bowel function are excluded from the study.
Sexes Eligible for Study: All
2 Years to 16 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
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Line Modin, Vejle Hospital
Line Modin
  • University of Southern Denmark
  • Kolding Sygehus
Not Provided
Vejle Hospital
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP