Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders
|First Received Date ICMJE||September 29, 2010|
|Last Updated Date||November 27, 2013|
|Start Date ICMJE||August 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT01212016 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders|
|Official Title ICMJE||Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders|
- 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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||400|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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 must:
-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.
-Probable eosinophilic esophagitis: Have a likely diagnosis of eosinophilic esophagitis, based on evidence of esophageal dysfunction and a peak count of greater than or equal to 15 eosinophils per high powered field, but for which the biopsy was not obtained under proton pump inhibitors (per section 6.3). To confirm
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  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:
Healthy, Non-Atopic Subjects:
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)
Subjects with EoE and EG undergoing research EGD or lymphapheresis must:
1. 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:
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:
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:
EGID subjects who are pregnant or breast-feeding may be followed without research phlebotomy.
|Ages||18 Years to 65 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT01212016|
|Other Study ID Numbers ICMJE||100196, 10-I-0196|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||February 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP