Clinical trial NCT00398021: Predictors of Constipation in Healthy Children
Official title: Predictors of Constipation in Healthy Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Constipation
Keywords: constipation
bowel habits
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2006-11-10
Enrollment: 1430
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 5 through 8 who present for a health maintenance visit at eleven general pediatric offices.

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.

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.

Eligibility criteria: Inclusion Criteria:

* presenting for a health maintenance visit

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Group Health Pediatrics- Capital
state: Wisconsin
city: Madison
country: United States
facility: UW East Pediatric Clinic
state: Wisconsin
city: Madison
country: United States
facility: UW East Towne Pediatrics
state: Wisconsin
city: Madison
country: United States
facility: Associated Physicians Pediatric Clinic
state: Wisconsin
city: Madison
country: United States
facility: University Station Pediatrics
state: Wisconsin
city: Madison
country: United States
facility: UW Pediatrics Fitchburg
state: Wisconsin
city: Madison
country: United States
facility: Access Community Health Centers
state: Wisconsin
city: Madison
country: United States
facility: UW Pediatrics-Park St.
state: Wisconsin
city: Madison
country: United States
facility: UW West Pediatric Clinic
state: Wisconsin
city: Madison
country: United States
facility: UW West Towne Pediatrics
state: Wisconsin
city: Stoughton
country: United States
facility: UW Pediatrics Stoughton
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ellen R Wald, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levine MD. Children with encopresis: A descriptive analysis. Pediatrics. 1975 Sep;56(3):412-6.
citation: Partin JC, Hamill SK, Fischel JE, Partin JS. Painful defecation and fecal soiling in children. Pediatrics. 1992 Jun;89(6 Pt 1):1007-9.
citation: 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.
citation: 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.
citation: 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.