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| Tracking Information | |||||
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| First Received Date ICMJE | November 8, 2006 | ||||
| Last Updated Date | May 16, 2008 | ||||
| Start Date ICMJE | June 2006 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00398021 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Predictors of Constipation in Healthy Children | ||||
| Official Title ICMJE | Predictors of Constipation in Healthy Children | ||||
| Brief 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Cohort, Other | ||||
| Condition ICMJE | Constipation | ||||
| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1430 | ||||
| Estimated Completion Date | June 2009 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 5 Years to 8 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00398021 | ||||
| Responsible Party | Ellen R. Wald, MD, University of Wisconsin-Madison Department of Pediatrics | ||||
| Study ID Numbers ICMJE | M-2006-1168 | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Investigators ICMJE |
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| Information Provided By | University of Wisconsin, Madison | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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