NCT00398021

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,430

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2006

Typical duration for all trials

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

October 5, 2015

Status Verified

June 1, 2010

Enrollment Period

3 years

First QC Date

November 8, 2006

Last Update Submit

October 1, 2015

Conditions

Keywords

constipationbowel habits

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children ages 5 through 8 who present for a health maintenance visit at eleven general pediatric offices.

You may qualify if:

  • presenting for a health maintenance visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Group Health Pediatrics- Capital

Madison, Wisconsin, 53703, United States

Location

UW East Pediatric Clinic

Madison, Wisconsin, 53704, United States

Location

UW East Towne Pediatrics

Madison, Wisconsin, 53704, United States

Location

Associated Physicians Pediatric Clinic

Madison, Wisconsin, 53705, United States

Location

University Station Pediatrics

Madison, Wisconsin, 53705, United States

Location

UW Pediatrics Fitchburg

Madison, Wisconsin, 53711, United States

Location

Access Community Health Centers

Madison, Wisconsin, 53713, United States

Location

UW Pediatrics-Park St.

Madison, Wisconsin, 53713, United States

Location

UW West Pediatric Clinic

Madison, Wisconsin, 53717, United States

Location

UW West Towne Pediatrics

Madison, Wisconsin, 53717, United States

Location

UW Pediatrics Stoughton

Stoughton, Wisconsin, 53589, United States

Location

Related Publications (5)

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

    PMID: 1161398BACKGROUND
  • Partin JC, Hamill SK, Fischel JE, Partin JS. Painful defecation and fecal soiling in children. Pediatrics. 1992 Jun;89(6 Pt 1):1007-9.

    PMID: 1594338BACKGROUND
  • 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.

    PMID: 8244110BACKGROUND
  • 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.

    PMID: 14676600BACKGROUND
  • 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.

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ellen R Wald, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 10, 2006

Study Start

June 1, 2006

Primary Completion

June 1, 2009

Study Completion

March 1, 2010

Last Updated

October 5, 2015

Record last verified: 2010-06

Locations