This trial is active, not recruiting.

Conditions constipation, fecal incontinence
Sponsor Medical College of Wisconsin
Collaborator Takeda Pharmaceuticals North America, Inc.
Start date September 2005
End date March 2012
Trial size 800 participants
Trial identifier NCT00677508, CHW 05/154


We propose to develop parent and child disease-specific instruments to assess health related quality of life (HRQoL) in children with constipation and fecal incontinence.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Children with constipation and fecal incontinence.
Children with constipation but without fecal incontinence.
Parents of children with constipation and/or fecal incontinence.

Primary Outcomes

To develop and validate child and parent questionnaires to assess HRQoL of children with chronic constipation and fecal incontinence.
time frame: 2 years

Eligibility Criteria

All participants from 2 years up to 18 years old.

Inclusion criteria: 1. Age 2-18 years 2. Child and parents fluent in English 3. Child must meet one of the following criteria; A. Constipation and fecal incontinence: must include 2 or more of the following in a child with insufficient criteria for a diagnosis of IBS (criteria fulfilled at least once per week for at least 2 months before diagnosis in a child over 4 years of age and for at least one month in a child less than 4 years of age): 1. Two or fewer defecations in the toilet per week 2. At least 1 episode of fecal incontinence per week 3. History of retentive posturing or excessive volitional stool retention 4. History of painful or hard bowel movements 5. Presence of a large fecal mass in the rectum 6. History of large diameter stools that may obstruct the toilet B. Constipation predominant IBS: must include the following, once a week for at least 2 months: 1. Abdominal pain/discomfort, associated with 2 of the following: - improved with defecation - onset associated with 2 or less stools per week - onset associated with hard or lump stool 2. no evidence of inflammatory, anatomic, metabolic or neoplastic processes. C. Non retentive fecal incontinence: must include all of the following in a child with a developmental age of at least 4 years (criteria fulfilled at least once per week for at least 2 months before diagnosis) [4]: 1. Defecation into places inappropriate to the social context at least once per month. 2. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process that explains the subject's symptoms 3. No evidence of fecal retention. Exclusion criteria: 1. Children with developmental delays and children over 12 years of age who are unable to understand the questionnaires. 2. Associated chronic disease which may have an impact on quality of life such as cerebral palsy, spine deformity or malformations, learning difficulties, severe mental illness, celiac disease, etc. 3. Child and parents not fluent in English.

Additional Information

Official title Development of an Instrument to Measure Quality of Life in Children With Chronic Constipation and Soiling
Principal investigator Manu Sood, MD
Description Chronic constipation is a common problem in childhood, accounting for almost 3% of consultations in pediatric practice. In many children constipation is accompanied by overflow soiling (fecal incontinence). This condition often gives rise to behavioral, social, and emotional problems. We plan to develop a disease-specific instrument to assess HRQoL in children with constipation and fecal incontinence. We hypothesize that HRQoL is worse in children with fecal incontinence compared to children with constipation but no fecal incontinence. The instrument will involve both parent and child self-reporting measures and will enable researchers to evaluate how disease and treatment strategies impact both child and parent perceptions of quality of life. In the long run this will enable physicians to develop a child friendly approach to management of chronic constipation and fecal incontinence.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Medical College of Wisconsin.