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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT01212016 |
Purpose
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:
Eligibility:
Design:
| Condition |
|---|
|
Food Hypersensitivity Eosinophilia Peanut Hypersensitivity |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders |
| Estimated Enrollment: | 400 |
| Study Start Date: | August 2010 |
Food allergy refers to a number of disorders characterized by clinical diseases associated with abnormal immune responses to food antigens. Classical IgE mediated anaphylactic food allergy is characterized by immediate hypersensitivity, and has a prevalence of approximately 6% and 3% in children and adults, respectively. In contrast, eosinophil associated gastrointestinal disorders (EGIDs), including eosinophilic esophagitis (EoE) and eosinophilic gastroenteritis (EG), are food allergy associated disorders characterized by eosinophilic inflammation of the gut, typically without anaphylaxis. Progress in the treatment and management of these food allergies requires further understanding of the immunological pathogenesis of these disorders. A subset of peripheral blood food allergen specific interleukin (IL) -5 producing T cells that are present in EGID but not peanut allergic subjects has recently been characterized. The primary objective of this study is to determine if similar IL-5 producing T cells are present in the gut of EGID subjects. To this end, both EGID and healthy non-allergic subjects will be enrolled and gastrointestinal biopsies will be obtained for intracellular cytokine staining, RT-PCR and ELISA.
Additionally, this protocol will supply blood and leukapheresis samples for exploratory studies on immunologic mechanisms underlying anaphylactic food allergy and EGIDs. A total of up to 400 subjects recruited from outside physician referrals and support groups, as well as from those in existing National Institutes of Health (NIH) protocols will be enrolled in this Clinical Center study.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Subjects must meet all of the inclusion criteria:
All Subjects must:
In addition to the above inclusion criteria for all subjects, the subjects in the following groups must meet additional group-specific inclusion criteria.
Subjects with EGID:
Eosinophilic gastroenteritis: Have a clinical history of eosinophilic gastroenteritis -including gastrointestinal symptoms-, and histological evidence of stomach or duodenal eosinophilia with no other known etiology for the eosinophilia despite careful clinical evaluation.
OR
Eosinophilic esophagitis: Have a diagnosis of eosinophilic esophagitis, including evidence of esophageal dysfunction with a peak count of greater than or equal to 25 eosinophils per high powered field, for which the biopsy was obtained while under proton pump inhibitor treatment.
OR
a diagnosis of EoE, these subjects may be treated with proton pump inhibitor therapy at recommended doses for gastroesophageal reflux disease for at least 84 weeks prior to EGD and biopsy. The decision to recommend diagnostic biopsy will be according to concensus guidelines [7] and current standards of care: based on the severity of symptoms, history of food impactions, and evidence of remodeling (strictures).
Subjects with Peanut Allergy:
Subjects with Other Allergic and Inflammatory Diseases:
These subjects must be diagnosed with an allergic or an inflammatory disease, including anaphylaxis, asthma, or hay fever. Diagnosis will be based on established criteria for each clinical entity.
Healthy, Non-Atopic Subjects:
EXCLUSION CRITERIA:
Subjects with any of the following criteria will be excluded:
1. 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:
1. Chronic upper GI symptoms that are consistent with EGID (dysphagia, nausea, vomiting, abdominal pain/cramps, early satiety)
PROCEDURAL INCLUSIONS:
All Subjects must:
Subjects with EG undergoing EGD or lymphapheresis must have:
Subjects with either EG or EoE undergoing lymphapheresis must have:
1. An absolute eosinophil count of > 750 eos/microL at least once in the last 2 years
Subjects with EoE undergoing EGD must have:
PROCEDURAL EXCLUSIONS:
Subjects with any of following will not undergo EGD:
Subjects with any of following will not undergo EGD or lymphapheresis:
Control Subjects (Healthy, Non-Atopic) Undergoing EGD with any of the following will be excluded:
Contacts and Locations| Contact: Calman P Prussin, M.D. | (301) 496-1306 | cprussin@niaid.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | Calman P Prussin, M.D. | National Institute of Allergy and Infectious Diseases (NIAID) |
More Information
| ClinicalTrials.gov Identifier: | NCT01212016 History of Changes |
| Other Study ID Numbers: | 100196, 10-I-0196 |
| Study First Received: | September 29, 2010 |
| Last Updated: | May 11, 2012 |
| Health Authority: | United States: Federal Government |
|
Eosinophilic Esophagitis Eosinophilic Gastroenteritis Peanut Allergy |
T Cell IgE Food Allergy |
|
Eosinophilia Food Hypersensitivity Gastrointestinal Diseases Hypersensitivity Peanut Hypersensitivity |
Leukocyte Disorders Hematologic Diseases Hypersensitivity, Immediate Immune System Diseases Digestive System Diseases |