Status:
COMPLETED
Abdominal Symptom Phenotype Study in Children
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
National Institute of Nursing Research (NINR)
University of Washington
Conditions:
Irritable Bowel Syndrome (IBS)
Eligibility:
FEMALE
7-12 years
Brief Summary
Children and adults commonly suffer from recurrent abdominal (stomach) pain. One type is called irritable bowel syndrome (IBS). IBS in adults and children is one of the most common and costly health c...
Detailed Description
Functional gastrointestinal (GI) disorders (FGIDs), in particular irritable bowel syndrome (IBS) in adults and children, are among the most common and costly health care problems in the US. IBS dispro...
Eligibility Criteria
Inclusion
- IBS:
- Age 7-12 years
- Females
- Meet criteria for irritable bowel syndrome without evidence of organic disease
- Developmentally normal
- English speaking (as the psychological measures are either not available or validated in Spanish)
- No other chronic, significant (e.g., diabetes, migraines) medical conditions
- No menses
- Controls:
- Age 7-12 years
- Females
- No abdominal pain
- No GI or chronic medical conditions (e.g., diabetes)
- Developmentally normal
- English speaking (as the psychological measures are not available or validated in Spanish)
- No menses
Exclusion
- Non-english speaking
- Developmentally or cognitively impaired
- Males
- Menses
- No mother in the household for administration of the psychological measures
- Use of any anti-depressants
- History of migraines or chronic pain disorders
- On narcotics for at least 1 week prior to enrollment
- On any NSAIDs or pain reliever for at least 24 hours prior to enrollment
- Sought psychotherapy in past 6 months for abdominal pain
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01204515
Start Date
June 1 2010
End Date
August 1 2012
Last Update
February 6 2013
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030