RECRUITING

Natural History and Genetics of Food Allergy and Related Conditions

Conditions

Food Allergy Loeys-Dietz Syndrome Atopic Dermatitis Eosinophilic Esophagitis TGFbeta Natural History

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Natural History and Genetics of Food Allergy and Related Conditions

Quick Facts

Study Start:2015-07-29

Study Completion:2026-06-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02504853

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Day to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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. 2. 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 3. Required to have a primary care or other physician who will manage all health conditions related or unrelated to the study objectives 1. 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) 2. 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) 3. 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) 4. Have a diagnosis of eosinophilic esophagitis (EoE), or clinical suspicion for EoE as determined by the principal investigator (PI) or associate investigators (AIs) 5. Have a history of atopic dermatitis based on self-report or physician assessment. 1. Be a relative of an affected participant 2. Be unaffected by food allergy (as determined by clinical history and/or allergy testing) or be unaffected by the genetic condition under study 1. Be unrelated to an affected participant 2. Be unaffected by food allergy (as determined by clinical history and/or allergy testing) or be unaffected by the genetic condition under study	* 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. 1. 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) 2. history of adverse reaction to conscious sedation or general anesthesia required for endoscopy 3. hemoglobin \< 11 g/dL 4. platelet count \< 100,000 microL 5. PT INR \>1.3 or PTT prolonged by \> 3 seconds 6. pregnant or breastfeeding 7. viral screens positive for HIV or hepatitis B or C 8. severe unstable myocardial ischemia or cardiomyopathy 9. severe hypoxemia due to chronic pulmonary disease 10. recent abdominal surgery 11. anticoagulant therapy that cannot be interrupted 12. 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 13. chronic GI or immunologic disease 14. clinically indicated EGD or colonoscopy within the past 12 months 15. use of systemic or inhaled corticosteroids within the past 4 months 16. have a history of EGID including EoE 17. younger than 18 years of age

Inclusion Criteria

Exclusion Criteria

1. 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.
2. 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
3. Required to have a primary care or other physician who will manage all health conditions related or unrelated to the study objectives
1. 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)
2. 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)
3. 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)
4. Have a diagnosis of eosinophilic esophagitis (EoE), or clinical suspicion for EoE as determined by the principal investigator (PI) or associate investigators (AIs)
5. Have a history of atopic dermatitis based on self-report or physician assessment.
1. Be a relative of an affected participant
2. Be unaffected by food allergy (as determined by clinical history and/or allergy testing) or be unaffected by the genetic condition under study
1. Be unrelated to an affected participant
2. Be unaffected by food allergy (as determined by clinical history and/or allergy testing) or be unaffected by the genetic condition under study

* 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.
1. 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)
2. history of adverse reaction to conscious sedation or general anesthesia required for endoscopy
3. hemoglobin \< 11 g/dL
4. platelet count \< 100,000 microL
5. PT INR \>1.3 or PTT prolonged by \> 3 seconds
6. pregnant or breastfeeding
7. viral screens positive for HIV or hepatitis B or C
8. severe unstable myocardial ischemia or cardiomyopathy
9. severe hypoxemia due to chronic pulmonary disease
10. recent abdominal surgery
11. anticoagulant therapy that cannot be interrupted
12. 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
13. chronic GI or immunologic disease
14. clinically indicated EGD or colonoscopy within the past 12 months
15. use of systemic or inhaled corticosteroids within the past 4 months
16. have a history of EGID including EoE
17. younger than 18 years of age

Contacts and Locations

Study Contact

Ellen Zektser, R.N.

CONTACT

Not Listed

niaidfars@niaid.nih.gov

Pamela A Guerrerio, M.D.

CONTACT

(301) 402-9782

pamela.guerrerio@nih.gov

Principal Investigator

Pamela A Guerrerio, M.D.

PRINCIPAL_INVESTIGATOR

National Institute of Allergy and Infectious Diseases (NIAID)

Study Locations (Sites)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

United States

Collaborators and Investigators

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Pamela A Guerrerio, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Allergy and Infectious Diseases (NIAID)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2015-07-29

Study Completion Date2026-06-15

Study Record Updates

Study Start Date2015-07-29

Study Completion Date2026-06-15

Terms related to this study

Keywords Provided by Researchers

Eosinophilic Esophagitis
Loeys-Dietz Syndrome
Atopic Dermatitis
TGFbeta
Natural History

Additional Relevant MeSH Terms

Food Allergy
Loeys-Dietz Syndrome
Atopic Dermatitis
Eosinophilic Esophagitis