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OpenTrials
Completed

NCT Number: NCT01566409

Maintenance Treatment for Children With Constipation

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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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, 6000, Denmark

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 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.

Treatment and study plan

Polyethylene glycol 3350

Drug

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

Placebo

Other

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.

Primary outcomes

  1. Treatment Recovery

    Time frame: ½ year

    Recovery is defined as the child having no symptoms of constipation according to the Rome III criteria.

Secondary outcomes

  1. Usage of Laxative

    Time frame: ½ year

Sponsors and collaborators

Lead sponsor

Line Modin

Other

Collaborators

  • Kolding Sygehus
  • University of Southern Denmark

Registry information

Official study title

Maintenance Treatment With Polyethylene Glycol 3350 for Children With Constipation. A Randomized, Placebocontrolled Intervention Study

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 29, 2012
Registry last updated
Sep 28, 2016

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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