ConstipationNCT00398021
Predictors of Constipation in Healthy Children
An observational study of Constipation, run by University of Wisconsin, Madison at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation
- How many people
- 1,430 participants
- Where
- 11 sitesUnited States
- Study dates
- Jun 2006to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children ages 5 through 8 who present for a health maintenance visit at eleven general pediatric offices.
Who may be able to join
- presenting for a health maintenance visit
Who cannot join
None listed.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Group Health Pediatrics- Capital
Madison, Wisconsin, 53703
UW East Pediatric Clinic
Madison, Wisconsin, 53704
UW East Towne Pediatrics
Madison, Wisconsin, 53704
Associated Physicians Pediatric Clinic
Madison, Wisconsin, 53705
University Station Pediatrics
Madison, Wisconsin, 53705
UW Pediatrics Fitchburg
Madison, Wisconsin, 53711
Access Community Health Centers
Madison, Wisconsin, 53713
UW Pediatrics-Park St.
Madison, Wisconsin, 53713
UW West Pediatric Clinic
Madison, Wisconsin, 53717
UW West Towne Pediatrics
Madison, Wisconsin, 53717
UW Pediatrics Stoughton
Stoughton, Wisconsin, 53589
About this study
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.
Read the 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.
- Conditions
- Constipation
- Keywords
- constipation, bowel habits
- Medical subject headings
- Constipation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study startJun 2006
- Primary completionJun 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 1,430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Ellen R Wald, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00398021
- Sponsor's protocol ID
- M-2006-1168
- Status last verified
- Jun 2010
- First submitted
- 8 Nov 2006
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Levine MD. Children with encopresis: A descriptive analysis. Pediatrics. 1975 Sep;56(3):412-6.
PubMed 1161398Partin JC, Hamill SK, Fischel JE, Partin JS. Painful defecation and fecal soiling in children. Pediatrics. 1992 Jun;89(6 Pt 1):1007-9.
PubMed 1594338Loening-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.
PubMed 8244110Loening-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.
PubMed 14676600Wald 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.
PubMed 21617560
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Constipation in Healthy Children
- ClinicalTrials.gov ID
- NCT00398021
- Acronym / sponsor ID
- M-2006-1168
- Conditions
- Constipation
- Keywords
- constipation, bowel habits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,430 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- Jun 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 10 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children ages 5 through 8 who present for a health maintenance visit at eleven general pediatric offices.
Key inclusion criteria (1 listed)
- presenting for a health maintenance visit
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
- Background: PubMed 1161398Levine MD. Children with encopresis: A descriptive analysis. Pediatrics. 1975 Sep;56(3):412-6.
- Background: PubMed 1594338Partin JC, Hamill SK, Fischel JE, Partin JS. Painful defecation and fecal soiling in children. Pediatrics. 1992 Jun;89(6 Pt 1):1007-9.
- Background: PubMed 8244110Loening-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.
- Background: PubMed 14676600Loening-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.
- Derived from this study: PubMed 21617560Wald 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen R Wald, MD principal investigator
University of Wisconsin, Madison
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation, run by University of Wisconsin, Madison at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00398021, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.