Natural History and Genetics of Food Allergy and Related Conditions
National Institute of Allergy and Infectious Diseases (NIAID)
1,800 participants
Jul 29, 2015
OBSERVATIONAL
Conditions
Summary
Background: \- About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them. Objective: \- To learn more about the causes and effects of food allergy and related conditions. Eligibility: * People ages 2 99 who have food allergy and/or a related genetic or other condition * Their relatives * Healthy relatives and volunteers Design: * Participants will have at least 3 visits over 1 2 years, and then once a year for up to 12 years. Each may last a day or longer. * Participants will be screened with medical history, physical exam, and questionnaires. * Participants may have the following: * Blood tests * Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is scratched under each drop. * Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and returned through a needle in the other arm. * X-rays * Esophageal string test: One end of a string is taped to the cheek and the other end is packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in for at least 1 hour. * EGD and colonoscopy: Biopsies are taken from the gastrointestinal system. * Tiny biopsies of skin * Photographs of the body * Collection of cells through: * Swab of nose, inside of cheek, or skin * Gentle skin scrape * Tape stripping: piece of tape is put on the skin and pulled off.
Eligibility
Inclusion Criteria18
- All participants must meet the following criteria:
- Be 2 to 99 years-old at the time of enrollment for participants who will be seen at the NIH CC; be 0 (newborn) to 99 years-old at the time of enrollment for participants who will submit mail-in samples or participate in telehealth visits. Only viable neonates will be enrolled.
- Willing to allow storage of blood, buccal swabs, saliva, nasal swabs, stool samples, and other clinically appropriate tissue specimens for future use in medical research
- Required to have a primary care or other physician who will manage all health conditions related or unrelated to the study objectives
- In addition to the general criteria listed above, affected participants must meet 1 of the following criteria:
- Have a clinical history of an immediate hypersensitivity reaction to food(s) and be sensitized to food allergen(s) (as evidenced by positive SPT or allergen-specific IgE testing)
- Be sensitized (as evidenced by positive SPT or allergen-specific IgE testing) to food allergen(s) but have no overt clinical history of IgE-mediated symptoms when they eat that food(s)
- Have a suspected genetic or congenital disorder potentially associated with food allergy or related condition, as determined by the principal investigator (PI) or associate investigators (AIs)
- Have a diagnosis of eosinophilic esophagitis (EoE), or clinical suspicion for EoE as determined by the principal investigator (PI) or associate investigators (AIs)
- Have a history of atopic dermatitis based on self-report or physician assessment.
- In addition to the general criteria listed above, unaffected relatives must meet the following criteria:
- Be a relative of an affected participant
- Be unaffected by food allergy (as determined by clinical history and/or allergy testing) or be unaffected by the genetic condition under study
- In addition to the general criteria listed above , healthy volunteers must meet the following criteria:
- Be unrelated to an affected participant
- Be unaffected by food allergy (as determined by clinical history and/or allergy testing) or be unaffected by the genetic condition under study
- Age greater than or equal to 18 years
- Stable hematologic parameters (definition: white blood cell count > 2,500/microL, hemoglobin > 10 g/dL, and platelet count > 75,000/microL)
Exclusion Criteria21
- Participants will be excluded for any of the following:
- Presence of conditions that, in the judgment of the investigator or the referring physician, may put the participant at undue risk or make them unsuitable for participation in the study.
- Inability to participate for the duration of the study.
- The PI deems that participation in the study would not be expected to advance the study goals.
- uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist s. Physical Status Classification System (http://www.asahq.org/resources/clinicalinformation/.asa-physical-status-classification-system)
- history of adverse reaction to conscious sedation or general anesthesia required for endoscopy
- hemoglobin < 11 g/dL
- platelet count < 100,000 microL
- PT INR >1.3 or PTT prolonged by > 3 seconds
- pregnant or breastfeeding
- viral screens positive for HIV or hepatitis B or C
- severe unstable myocardial ischemia or cardiomyopathy
- severe hypoxemia due to chronic pulmonary disease
- recent abdominal surgery
- anticoagulant therapy that cannot be interrupted
- history of reflux disease within the last 3 years or use of acid-suppression medication (including over-the-counter medications such as Tums, Rolaids, Zantac, Prilosec OTC, or Prevacid OTC) within the last 2 months
- chronic GI or immunologic disease
- clinically indicated EGD or colonoscopy within the past 12 months
- use of systemic or inhaled corticosteroids within the past 4 months
- have a history of EGID including EoE
- younger than 18 years of age
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT02504853