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NCT01212016 · ClinicalTrials.gov registry record
Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- 162
- Enrollment target
NCT01212016: Clinical Trial study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01212016 is a clinical trial that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 162 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01212016 was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- 162 participants
- Enrollment target
Study Summary
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 leukapheris
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2010-08-30 |
| Est. Completion | 2015-05-13 |
Why NCT01212016 stopped before completion
NCT01212016 is an observational study that tracks outcomes without assigning an intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01212016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01212016 about?
NCT01212016 is a clinical study titled "Immunopathogenesis of Food Allergy and Eosinophilic Gastrointestinal Disorders". 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 se...
What is the current status of trial NCT01212016?
This trial is currently terminated. The enrollment target is 162 participants. The study started on 2010-08-30. Estimated completion is 2015-05-13.
Who is sponsoring clinical trial NCT01212016?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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