Outpatient Treatment of Constipation in Children

Outpatient Treatment of Constipation in Children - a Randomized Interventions Study

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Other: Telephone counseling; Other: Web access

• Study Type: Interventional
• Enrollment (Actual): 239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Kolding, Denmark, 6000
    • Line Modin
  • Kolding, Denmark, 6000
    • Pediatric department, Kolding Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No ekstra counseling; Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made.
Active Comparator: 2 counseling sessions; Standardized information about childhood constipation is given and the child receives PEG 3350. 2 additional follow up appointments by telephone are made.	Other: Telephone counseling; 2 planned telephone counseling sessions are conducted.; Other Names: Telephone
Active Comparator: Web access; Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made but the family are given access to a website with information about childhood constipation.	Other: Web access; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment recovery	Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usage of laxative.	Amount of laxative used during the study periode.	1 year
Telephone contacts	Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted.	1 year

Collaborators and Investigators

• Sponsor: Line Modin
• Collaborators: University of Southern Denmark
• Investigators: Study Director: Marianne Jakobsen, MD, PhD, Kolding; Study Chair: Poul Erik Kofoed, MD. PHD, Kolding; Principal Investigator: Line Modin, MD, Kolding

Publications and helpful links

General Publications

• Modin L, Walsted AM, Rittig CS, Hansen AV, Jakobsen MS. Follow-up in Childhood Functional Constipation: A Randomized, Controlled Clinical Trial. J Pediatr Gastroenterol Nutr. 2016 Apr;62(4):594-9. doi: 10.1097/MPG.0000000000000974.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: April 19, 2012
• First Posted (Estimate): April 20, 2012

Study Record Updates

• Last Update Posted (Estimate): December 5, 2014
• Last Update Submitted That Met QC Criteria: December 4, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: children; outpatient; constipation
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: OutCon