Evaluation of Food Hypersensitivity in Children/Adolescents With Functional Dyspepsia

Completed · Phase 1

Conditions studied: Dyspepsia

In brief

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 of dyspepsia and helpful in designing a treatment plan. The study will also determine if there is a connection between positive allergy tests and inflammation in the upper abdomen.

Key facts

Study ID

NCT00328679

Run by

Children's Mercy Hospital Kansas City

People needed

41

Starts

2006-06-01

Expected to finish

2008-09-01

Last updated by the study team

2008-10-08

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• The Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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