Predictors of Constipation in Healthy Children

October 1, 2015 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

1430

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53713
        • Access Community Health Centers
      • Madison, Wisconsin, United States, 53703
        • Group Health Pediatrics- Capital
      • Madison, Wisconsin, United States, 53704
        • UW East Pediatric Clinic
      • Madison, Wisconsin, United States, 53704
        • UW East Towne Pediatrics
      • Madison, Wisconsin, United States, 53705
        • Associated Physicians Pediatric Clinic
      • Madison, Wisconsin, United States, 53705
        • University Station Pediatrics
      • Madison, Wisconsin, United States, 53711
        • UW Pediatrics Fitchburg
      • Madison, Wisconsin, United States, 53713
        • UW Pediatrics-Park St.
      • Madison, Wisconsin, United States, 53717
        • UW West Pediatric Clinic
      • Madison, Wisconsin, United States, 53717
        • UW West Towne Pediatrics
      • Stoughton, Wisconsin, United States, 53589
        • UW Pediatrics Stoughton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • presenting for a health maintenance visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Boehringer Ingelheim

Investigators

  • Principal Investigator: Ellen R Wald, MD, University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

November 8, 2006

First Submitted That Met QC Criteria

November 9, 2006

First Posted (Estimate)

November 10, 2006

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 1, 2015

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-2006-1168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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