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Protocol Details

Natural History and Genetics of Food Allergy and Related Conditions

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-I-0162

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2
Max Age: 99

Referral Letter Required

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

Eosinophilic Esophagitis;
Loeys-Dietz Syndrome;
TGFbeta

Recruitment Keyword(s)

None

Condition(s)

Food Allergy;
Loeys-Dietz Syndrome

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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.

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Eligibility

GENERAL INCLUSION CRITERIA:

All participants must meet the following 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

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

ADDITIONAL INCLUSION CRITERIA FOR AFFECTED PARTICIPANTS

In addition to the general criteria listed above, affected participants must meet 1 of the following criteria:

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)

Additionally, participants who meet criteria 1 or 3 must have a primary physician outside of the NIH who must submit a letter or clinical summary that documents the participant s relevant health history.

ADDITIONAL INCLUSION CRITERIA FOR UNAFFECTED RELATIVES:

In addition to the general criteria listed above, unaffected relatives must meet the following criteria:

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

ADDITIONAL INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS

In addition to the general criteria listed above , healthy volunteers must meet the following criteria:

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

ADDITIONAL PROCEDURE- SPECIFIC INCLUSION CRITERIA:

The following additional inclusion criteria apply for participants undergoing leukapheresis:

1. Age greater than or equal to 12 years for affected participants; age greater than or equal to 18 years for unaffected relatives and healthy volunteers

2. Stable hematologic paramaters (definition: white blood cell count > 2,500/ L, hemoglobin > 10 g/dL, and platelet count > 75,000/microliter)

GENERAL EXCLUSION CRITERIA:

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.

ADDITIONAL PROCEDURE- SPECIFIC EXCLUSION CRITERIA

Additional exclusion criteria apply for participants who are undergoing endoscopsy with biopsies strictly for research purposes. Participants will be excluded from participating in this procedure if they meet any of the following criteria:

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 < 12 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

Additionally, unaffected relatives and healthy volunteers will be excluded from endoscopy if they meet any of the following criteria:

1. history of reflux or use of acid-suppression medication (including over-the-counter medication) within the last 6 months

2. chronic GI or immunologic disease

3. clinically indicated EGD or colonoscopy within the past 12 months

4. use of systemic corticosteroids within the past 6 months

5. have a history of EGID including EoE

6. younger than 18 years of age


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Citations:

Boyce JA, Assa'ad A, Burks AW, Jones SM, Sampson HA, Wood RA, Plaut M, Cooper SF, Fenton MJ, Arshad SH, Bahna SL, Beck LA, Byrd-Bredbenner C, Camargo CA Jr, Eichenfield L, Furuta GT, Hanifin JM, Jones C, Kraft M, Levy BD, Lieberman P, Luccioli S, McCall KM, Schneider LC, Simon RA, Simons FE, Teach SJ, Yawn BP, Schwaninger JM. Guidelines for the diagnosis and management of food allergy in the United States: summary of the NIAID-sponsored expert panel report. Nutr Res. 2011 Jan;31(1):61-75. doi: 10.1016/j.nutres.2011.01.001.

Noval Rivas M, Burton OT, Wise P, Zhang YQ, Hobson SA, Garcia Lloret M, Chehoud C, Kuczynski J, DeSantis T, Warrington J, Hyde ER, Petrosino JF, Gerber GK, Bry L, Oettgen HC, Mazmanian SK, Chatila TA. A microbiota signature associated with experimental food allergy promotes allergic sensitization and anaphylaxis. J Allergy Clin Immunol. 2013 Jan;131(1):201-12. doi: 10.1016/j.jaci.2012.10.026. Epub 2012 Nov 30.

Frischmeyer-Guerrerio PA, Guerrerio AL, Oswald G, Chichester K, Myers L, Halushka MK, Oliva-Hemker M, Wood RA, Dietz HC. TGF <= receptor mutations impose a strong predisposition for human allergic disease. Sci Transl Med. 2013 Jul 24;5(195):195ra94. doi: 10.1126/scitranslmed.3006448.

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Contacts:

Principal Investigator

Referral Contact

For more information:

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



Caeden Dempsey
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 11N240B
10 Center Drive
Bethesda, Maryland 20892
(301) 761-7887
caeden.dempsey@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT02504853

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