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Predictors of Constipation in Healthy Children

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00398021
First received: November 8, 2006
Last updated: June 30, 2010
Last verified: June 2010
History of Changes
  Purpose

The purpose of this research is to see if a questionnaire on bowel habits can help identify children who will have constipation 12 months later.


Condition
Constipation

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Predictors of Constipation in Healthy Children

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Estimated Enrollment: 1430
Study Start Date: June 2006
Study Completion Date: March 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:

Constipation in children is a common complaint, accounting for an estimated 3% of all pediatric office visits and 20% of visits to a pediatric gastroenterologist. Unfortunately, constipation can become chronic in many children even before the problem has been recognized by a parent or primary care physician. We have previously characterized the bowel habits of more than 3300 primarily middle class Caucasian children 1 to 8 years of age presenting to their primary care practitioner for a health maintenance visit. However, the validity of information concerning bowel habits of children obtained by recall is not well established. The potential benefit of this study to society will be the demonstration that a bowel habit questionnaire can predict the outcome of clinically important constipation.

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children ages 5 through 8 who present for a health maintenance visit at eleven general pediatric offices.

Criteria

Inclusion Criteria:

  • presenting for a health maintenance visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398021

Locations
United States, Wisconsin
Associated Physicians Pediatric Clinic
Madison, Wisconsin, United States, 53705
University Station Pediatrics
Madison, Wisconsin, United States, 53705
UW East Pediatric Clinic
Madison, Wisconsin, United States, 53704
UW Pediatrics-Park St.
Madison, Wisconsin, United States, 53713
UW Pediatrics Fitchburg
Madison, Wisconsin, United States, 53711
Access Community Health Centers
Madison, Wisconsin, United States, 53713
UW East Towne Pediatrics
Madison, Wisconsin, United States, 53704
UW West Pediatric Clinic
Madison, Wisconsin, United States, 53717
UW West Towne Pediatrics
Madison, Wisconsin, United States, 53717
Group Health Pediatrics- Capital
Madison, Wisconsin, United States, 53703
UW Pediatrics Stoughton
Stoughton, Wisconsin, United States, 53589
Sponsors and Collaborators
University of Wisconsin, Madison
Boehringer Ingelheim Pharmaceuticals
Investigators
Principal Investigator: Ellen R Wald, MD University of Wisconsin, Madison
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ellen R. Wald, MD, University of Wisconsin-Madison Department of Pediatrics
ClinicalTrials.gov Identifier: NCT00398021     History of Changes
Other Study ID Numbers: M-2006-1168
Study First Received: November 8, 2006
Last Updated: June 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
constipation
bowel habits

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013