Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders

Stopped early

Conditions studied: Eosinophilic Gastroenteritis, Eosinophilic Esophagitis

In brief

Background: \- Food allergies are characterized by abnormal immune system responses to certain foods, such as peanuts, strawberries, and shellfish. Some individuals with these allergies have immediate allergic reactions on contact with the food in question and need immediate treatment to prevent severe complications. In contrast, eosinophil-associated gastrointestinal disorders are related disorders in which white blood cells in the intestinal tract react to certain foods, causing abdominal pain, nausea, and other digestion problems. Researchers are interested in studying these conditions to better understand how the immune system responds to food allergies. Objectives: * To examine how the immune system responds to food allergens. * To examine how certain white blood cells contribute to disease in individuals with food allergies and other inflammatory diseases. Eligibility: * Individuals between 18 and 65 years of age who have a history of (a) severe allergic reaction to peanuts (and have peanut-specific antibodies), (b) allergy or inflammatory disease, or (c) eosinophil-associated gastrointestinal disorder (with at least two documented food allergies). * Healthy volunteers between 18 and 65 years of age who have no known allergies or asthma. Design: * All participants will have a screening visit and a procedure visit. The procedure visit will take place within 30 to 60 days of the screening visit, and will take 3 to 4 hours depending on the procedure(s) done. * Participants will be screened with a physical examination and medical history, and will provide blood samples for testing. Participants with peanut or other allergies will have additional tests to determine their levels of sensitivity to certain foods. Participants with eosinophil-associated gastrointestinal disorder will provide stool samples for testing. * At the procedure visit, participants with peanut allergies and participants with other allergies will provide blood samples and have leukapherisis to collect white blood cells for examination. * At the procedure visit, healthy volunteers and participants with eosinophil-associated gastrointestinal disorder will provide blood samples and have leukapherisis to collect white blood cells for examination. In addition, some but not all of these participants will have a procedure called esophagogastroduodenoscopy (EGD), which will examine the esophagus, stomach, and small intestine. Participants who are scheduled to have EGD will be asked to fast for 6 hours before the procedure.

Key facts

Study ID

NCT01212016

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

162

Starts

2010-08-30

Expected to finish

2015-05-13

Last updated by the study team

2017-10-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Subjects with any of the following criteria will be excluded:
• Any other condition that, in the investigator s opinion, places the subject at undue risk by participating in the study
• Subjects with Peanut Allergy with any of the following will be excluded:
• Chronic upper GI symptoms that are consistent with EGID (dysphagia, nausea, vomiting, abdominal pain/cramps, early satiety)
• PROCEDURAL INCLUSIONS:
• Subjects with EoE and EG undergoing research EGD or lymphapheresis must:
• Be greater than or equal to 18 years of age and less than or equal to 65 years of age.
• Subjects with EG undergoing EGD or lymphapheresis must have:
• Histological evidence of stomach or duodenal eosinophilia with a peak count greater than or equal to 40 eosinophils per high powered field
• Greater than two positive allergen skin tests or antigen specific IgE tests out of the following panel (peanut, wheat, soy, shrimp, egg white, milk, walnut, cod, corn)
• Subjects with either EG or EoE undergoing lymphapheresis must have:
• An absolute eosinophil count of >750 eos/microL at least once in the last 2 years
• Subjects with EoE undergoing EGD must have:
• Diagnosed EoE per section 5.1 with a previous biopsy showing greater than or equal to 25 eosinophils per high powered field, OR
• Probable eosinophilic esophagitis per section 5.1 with a previous biopsy showing greater than or equal to 25 eosinophils per high powered field
• PROCEDURAL EXCLUSIONS:
• Subjects with any of following will not undergo EGD:
• Uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist s (ASA) Physical Status Classification System.
• History of adverse reaction to conscious sedation required for EGD.
• Subjects with any of following will not undergo EGD or lymphapheresis:
• Hemoglobin <12 g/dL
• Viral screens positive for HIV or hepatitis B or C
• Pregnant or breast-feeding women
• Control Subjects (Healthy, Non-Atopic) Undergoing EGD with any of the following will be excluded:
• History of reflux or use of acid suppression medication within the last 6 months.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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