Maintenance Treatment for Children With Constipation

NCT01566409 | Completed Results

• 1 other identifier: MainCon
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation

Keywords

Constipation; Maintenance treatment; Ultrasound of rectum

Outcome Measures

Primary Outcomes (1)

• Treatment Recovery

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

  ½ year

Secondary Outcomes (1)

• Usage of Laxative

  ½ year

Study Arms (2)

Active maintenance treatment

ACTIVE COMPARATOR

Drug: Polyethylene glycol 3350

Placebo maintenance treatment

PLACEBO COMPARATOR

Other: Placebo

Interventions

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.

Also known as: Movicol, Movicol junior, Moxalole, Lacrofarm

Active maintenance treatment

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.

Placebo maintenance treatment

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Line Modin: lead
• University of Southern Denmark: collaborator
• Kolding Sygehus: collaborator

Study Sites (1)

Line Modin

Kolding, 6000, Denmark

Location

MeSH Terms

Conditions

Constipation

Interventions

polyethylene glycol 3350

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Line Modin
• Organization: Pediatric Department, Hospital Lillebaelt, Kolding

line.modin@rsyd.dk

0045 61386349

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: March 29, 2012
• Study Start: September 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 28, 2016
• Results First Posted: September 28, 2016

Record last verified: 2016-08

Locations

DK (1)