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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.
U.S. FDA Resources
| Study Type: |
Observational |
| Study Design: |
Cohort, Other |
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| Official Title: |
Predictors of Constipation in Healthy Children |
Biospecimen Retention: None Retained
| Estimated Enrollment: |
1430 |
| Study Start Date: |
June 2006 |
| Estimated Study Completion Date: |
June 2009 |
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.
| Ages Eligible for Study: |
5 Years to 8 Years |
| Genders Eligible for Study: |
Both |
| Accepts Healthy Volunteers: |
Yes |
| Sampling Method: |
Non-Probability Sample |
Children ages 5 through 8 who present for a health maintenance visit at eleven general pediatric offices.
Inclusion Criteria:
- presenting for a health maintenance visit
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398021
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| Associated Physicians Pediatric Clinic |
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| Madison, Wisconsin, United States, 53705 |
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| University Station Pediatrics |
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| Madison, Wisconsin, United States, 53705 |
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| UW East Pediatric Clinic |
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| Madison, Wisconsin, United States, 53704 |
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| UW Pediatrics-Park St. |
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| Madison, Wisconsin, United States, 53713 |
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| UW West Pediatric Clinic |
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| Madison, Wisconsin, United States, 53717 |
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| Access Community Health Centers |
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| Madison, Wisconsin, United States, 53713 |
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| UW East Towne Pediatrics |
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| Madison, Wisconsin, United States, 53704 |
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| UW Pediatrics Fitchburg |
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| Madison, Wisconsin, United States, 53711 |
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| UW Pediatrics Stoughton |
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| Stoughton, Wisconsin, United States, 53589 |
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| Group Health Pediatrics- Capital |
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| Madison, Wisconsin, United States, 53703 |
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| UW West Towne Pediatrics |
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| Madison, Wisconsin, United States, 53717 |
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| University of Wisconsin, Madison |
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| Boehringer Ingelheim Pharmaceuticals |
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| Principal Investigator: |
Ellen R Wald, MD |
University of Wisconsin, Madison |
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| Associated Physicians Pediatric Clinic |
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| Madison, Wisconsin, United States, 53705 |
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| University Station Pediatrics |
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| Madison, Wisconsin, United States, 53705 |
|
| UW East Pediatric Clinic |
|
| Madison, Wisconsin, United States, 53704 |
|
| UW Pediatrics-Park St. |
|
| Madison, Wisconsin, United States, 53713 |
|
| UW West Pediatric Clinic |
|
| Madison, Wisconsin, United States, 53717 |
|
| Access Community Health Centers |
|
| Madison, Wisconsin, United States, 53713 |
|
| UW East Towne Pediatrics |
|
| Madison, Wisconsin, United States, 53704 |
|
| UW Pediatrics Fitchburg |
|
| Madison, Wisconsin, United States, 53711 |
|
| UW Pediatrics Stoughton |
|
| Stoughton, Wisconsin, United States, 53589 |
|
| Group Health Pediatrics- Capital |
|
| Madison, Wisconsin, United States, 53703 |
|
| UW West Towne Pediatrics |
|
| Madison, Wisconsin, United States, 53717 |
|
| University of Wisconsin, Madison |
|
| Boehringer Ingelheim Pharmaceuticals |
|
| Principal Investigator: |
Ellen R Wald, MD |
University of Wisconsin, Madison |
Publications:
| Responsible Party: |
University of Wisconsin-Madison Department of Pediatrics ( Ellen R. Wald, MD ) |
| Study ID Numbers: |
M-2006-1168 |
| First Received: |
November 8, 2006 |
| Last Updated: |
May 16, 2008 |
| ClinicalTrials.gov Identifier: |
NCT00398021 |
| Health Authority: |
United States: Institutional Review Board |
Keywords provided by University of Wisconsin, Madison:
| constipation |
| bowel habits | |
Study placed in the following topic categories:
| Signs and Symptoms |
| Signs and Symptoms, Digestive |
| Constipation |
| Healthy | |
Additional relevant MeSH terms:
Source: National Library of Medicine (NLM) July 08, 2008
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