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NCT00398021 Clinical Trial

Predictors of Constipation in Healthy Children

Constipation Clinical Trial

Official title:
Predictors of Constipation in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00398021
Other study ID # M-2006-1168
Secondary ID
Status Completed
Phase N/A
First received November 8, 2006
Last updated October 1, 2015
Start date June 2006
Est. completion date March 2010

Study information
Verified date June 2010
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 1430
Est. completion date March 2010
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 5 Years to 8 Years
Eligibility Inclusion Criteria:

- presenting for a health maintenance visit

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
United States Access Community Health Centers Madison Wisconsin
United States Associated Physicians Pediatric Clinic Madison Wisconsin
United States Group Health Pediatrics- Capital Madison Wisconsin
United States University Station Pediatrics Madison Wisconsin
United States UW East Pediatric Clinic Madison Wisconsin
United States UW East Towne Pediatrics Madison Wisconsin
United States UW Pediatrics Fitchburg Madison Wisconsin
United States UW Pediatrics-Park St. Madison Wisconsin
United States UW West Pediatric Clinic Madison Wisconsin
United States UW West Towne Pediatrics Madison Wisconsin
United States UW Pediatrics Stoughton Stoughton Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
University of Wisconsin, Madison Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

References & Publications (4)

Levine MD. Children with encopresis: A descriptive analysis. Pediatrics. 1975 Sep;56(3):412-6. — View Citation

Loening-Baucke V. Constipation in early childhood: patient characteristics, treatment, and longterm follow up. Gut. 1993 Oct;34(10):1400-4. — View Citation

Loening-Baucke V. Functional fecal retention with encopresis in childhood. J Pediatr Gastroenterol Nutr. 2004 Jan;38(1):79-84. — View Citation

Partin JC, Hamill SK, Fischel JE, Partin JS. Painful defecation and fecal soiling in children. Pediatrics. 1992 Jun;89(6 Pt 1):1007-9. — View Citation

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