Predictors of Constipation in Healthy Children

NCT ID: NCT00398021

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-06-30

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Constipation

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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Inclusion Criteria

* presenting for a health maintenance visit
Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen R Wald, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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Group Health Pediatrics- Capital

Madison, Wisconsin, United States

Site Status

UW East Pediatric Clinic

Madison, Wisconsin, United States

Site Status

UW East Towne Pediatrics

Madison, Wisconsin, United States

Site Status

Associated Physicians Pediatric Clinic

Madison, Wisconsin, United States

Site Status

University Station Pediatrics

Madison, Wisconsin, United States

Site Status

UW Pediatrics Fitchburg

Madison, Wisconsin, United States

Site Status

Access Community Health Centers

Madison, Wisconsin, United States

Site Status

UW Pediatrics-Park St.

Madison, Wisconsin, United States

Site Status

UW West Pediatric Clinic

Madison, Wisconsin, United States

Site Status

UW West Towne Pediatrics

Madison, Wisconsin, United States

Site Status

UW Pediatrics Stoughton

Stoughton, Wisconsin, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 1161398 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 1594338 (View on PubMed)

Loening-Baucke V. Constipation in early childhood: patient characteristics, treatment, and longterm follow up. Gut. 1993 Oct;34(10):1400-4. doi: 10.1136/gut.34.10.1400.

Reference Type BACKGROUND
PMID: 8244110 (View on PubMed)

Loening-Baucke V. Functional fecal retention with encopresis in childhood. J Pediatr Gastroenterol Nutr. 2004 Jan;38(1):79-84. doi: 10.1097/00005176-200401000-00018.

Reference Type BACKGROUND
PMID: 14676600 (View on PubMed)

Wald ER, Jagodzinski TD, Moyer SC, Wald A, Eickhoff JC, Edmonson MB. Validation and clinical utility of a bowel habit questionnaire in school-age children. J Pediatr Gastroenterol Nutr. 2011 Nov;53(5):520-3. doi: 10.1097/MPG.0b013e31822504fb.

Reference Type DERIVED
PMID: 21617560 (View on PubMed)

Other Identifiers

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M-2006-1168

Identifier Type: -

Identifier Source: org_study_id

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