Status:
COMPLETED
Evaluation of Food Hypersensitivity in Children/Adolescents With Functional Dyspepsia
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Dyspepsia
Eligibility:
All Genders
8-17 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to determine if standard and investigational tests used to help diagnose and treat food allergies can provide information that will be useful in determining the cause...
Detailed Description
Recurrent abdominal pain is the most common type of pain in school age children and young adolescents. Over 80% of these children have pain in the upper abdomen which is diagnosed as functional dyspep...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age of 8-17 years, inclusive
- Diagnosis of functional dyspepsia (FD) by physician based on Rome II criteria (patient group only)
- Undergoing endoscopy to evaluate FD following demonstration of a lack of clinical response to acid reduction therapy (patient group only)
- Informed permission/assent
- Exclusion Criteria (patient goup):
- Previous testing for food-specific IgE, IgG, IgG4, skin prick or allergy patch tests within the past 12 months or any previous positive result(s) for food-specific IgE, IgG, IgG4, SPT or APT to milk, egg, soy, corn, peanut or wheat;
- Any use of steroids or leukotriene receptor antagonists within one month prior to the study
- Any use of antihistamines, antihistamine-like drugs or topical steroid within two weeks prior to the study
- Any chronic non-gastrointestinal illness requiring regular medical care
- Exclusion Criteria (healthy control group)
- In addition to patient exclusion criteria as defined above
- Any current or chronic history within the previous 6 months of gastrointestinal symptoms including abdominal pain or discomfort, nausea, vomiting, bloating, diarrhea or constipation
- History of asthma or chronic respiratory symptoms
- History of allergic rhinitis or chronic sinusitis
- History of allergic reactions attributed to food
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00328679
Start Date
June 1 2006
End Date
September 1 2008
Last Update
October 8 2008
Active Locations (1)
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1
The Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108