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Outpatient Treatment of Constipation in Children

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telephone counseling
Web access
Sponsored by
Line Modin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring constipation, children, outpatient

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Line Modin
  • Pediatric department, Kolding Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

No ekstra counseling

2 counseling sessions

Web access

Arm Description

Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made.

Standardized information about childhood constipation is given and the child receives PEG 3350. 2 additional follow up appointments by telephone are made.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Usage of laxative.
Amount of laxative used during the study periode.
Telephone contacts
Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted.

Full Information

First Posted
March 27, 2012
Last Updated
December 4, 2014
Sponsor
Line Modin
Collaborators
University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT01582659
Brief Title
Outpatient Treatment of Constipation in Children
Official Title
Outpatient Treatment of Constipation in Children - a Randomized Interventions Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Line Modin
Collaborators
University of Southern Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, children, outpatient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No ekstra counseling
Arm Type
No Intervention
Arm Description
Standardized information about childhood constipation is given and the child receives PEG 3350. No additional follow up appointments are made.
Arm Title
2 counseling sessions
Arm Type
Active Comparator
Arm Description
Standardized information about childhood constipation is given and the child receives PEG 3350. 2 additional follow up appointments by telephone are made.
Arm Title
Web access
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telephone counseling
Other Intervention Name(s)
Telephone
Intervention Description
2 planned telephone counseling sessions are conducted.
Intervention Type
Other
Intervention Name(s)
Web access
Other Intervention Name(s)
Web
Intervention Description
Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.
Primary Outcome Measure Information:
Title
Treatment recovery
Description
Recovery is defined as the child having no symptoms of constipation according to the Rome III chriteria.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Usage of laxative.
Description
Amount of laxative used during the study periode.
Time Frame
1 year
Title
Telephone contacts
Description
Number of telephone contacts during the study periode, both planned and unplanned contacts will be noted.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Jakobsen, MD, PhD
Organizational Affiliation
Kolding
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Poul Erik Kofoed, MD. PHD
Organizational Affiliation
Kolding
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Line Modin, MD
Organizational Affiliation
Kolding
Official's Role
Principal Investigator
Facility Information:
Facility Name
Line Modin
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Pediatric department, Kolding Hospital
City
Kolding
ZIP/Postal Code
6000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26348685
Citation
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.
Results Reference
derived

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Outpatient Treatment of Constipation in Children

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