NCT01582659

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2012

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 20, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

2.3 years

First QC Date

March 27, 2012

Last Update Submit

December 4, 2014

Conditions

Constipation

Keywords

constipationchildrenoutpatient

Outcome Measures

Primary Outcomes (1)

  • Treatment recovery

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

    1 year

Secondary Outcomes (2)

  • Usage of laxative.

    1 year

  • Telephone contacts

    1 year

Study Arms (3)

No ekstra counseling

NO INTERVENTION

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

2 counseling sessions

ACTIVE COMPARATOR

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

Web access

ACTIVE COMPARATOR

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

Interventions

Telephone counselingOTHER

2 planned telephone counseling sessions are conducted.

Also known as: Telephone
2 counseling sessions
Web accessOTHER

Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.

Also known as: Web
Web access

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Line Modin

Kolding, 6000, Denmark

Location

Pediatric department, Kolding Hospital

Kolding, 6000, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 26348685DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marianne Jakobsen, MD, PhD

    Kolding

    STUDY DIRECTOR

  • Poul Erik Kofoed, MD. PHD

    Kolding

    STUDY CHAIR

  • Line Modin, MD

    Kolding

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
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

April 20, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations

DK(2)