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Natural History and Genetics of Food Allergy and Related Conditions

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 3, 2017 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT02504853
First received: July 21, 2015
Last updated: May 9, 2017
Last verified: May 3, 2017
  Purpose

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.

Condition
Food Allergy
Loeys-Dietz Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Natural History and Genetics of Food Allergy and Related Conditions

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Investigate the key genetic, cellular, immunologic, microbial, and biochemical pathways that lead to the development of food allergy [ Time Frame: 06/15/2025 ]
  • Identify biomarkers that predict the clinical course and natural history of patients with food allergy [ Time Frame: 06/15/2025 ]

Secondary Outcome Measures:
  • The prevalence of eosinophilic GI disease in patients who might be considered to be at high risk for these conditions, including those patients with atopic dermatitis and/or multiple food sensitivities/allergies [ Time Frame: 06/15/2026 ]
  • Identification of nutritional deficiencies and their effect on the growth and overall health of patients with food allergy and related conditions [ Time Frame: 06/15/2026 ]
  • In vitro testing of novel therapies for food allergy using cells and other biological specimens obtained from patients with food allergy [ Time Frame: 06/15/2026 ]

Estimated Enrollment: 950
Study Start Date: June 30, 2015
Estimated Study Completion Date: March 31, 2030
Estimated Primary Completion Date: March 31, 2027 (Final data collection date for primary outcome measure)
Detailed Description:

There are approximately 15 million Americans, including 6 million children, who have a potentially life-threatening food allergy. The prevalence of this disease has increased over the last three decades, in both the United States and other developed countries. There are no cures or effective prevention or treatment strategies for food allergy. Moreover, little is known about the factors that account for the rising prevalence and severity of these diseases in recent years. Both genetic and environmental factors likely contribute to the development of food allergy, but the complex interaction between these variables has frustrated efforts to elucidate pathogenesis and develop mechanism-targeted therapies. Children with food allergy are 2 to 4 times more likely to be diagnosed with asthma or other allergic conditions than children without food allergy, and food allergy may also be an important trigger for atopic dermatitis and eosinophilic esophagitis. The Laboratory of Allergic Diseases within the National Institute of Allergy and Infectious Diseases has a longstanding interest in the genetics and pathogenesis of allergic inflammatory disorders, and with the National Institutes of Health Clinical Center, it provides the ideal environment for the proposed translational studies. In this study, we will: (1) investigate the key genetic, cellular, immunologic, and biochemical pathways that lead to the development of food allergy, and (2) identify biomarkers that predict the clinical course and natural history of patients with food allergy.

Subjects eligible for enrollment in this study include children and adults with food allergy and patients with a known/suspected genetic or congenital disorder potentially associated with these phenotypes. Unaffected relatives (children and adults) of an enrolled subject and healthy volunteers (children and adults) will also be eligible for enrollment as controls. Most participants will be followed for 2 years, although participants with an identified genetic or congenital disorder and a subset of participants with food allergy may be followed until this study ends (up to 12 years).

Data obtained from analysis of blood, skin, saliva, stool, gastrointestinal biopsies, and other specimens will be used to explore the immunologic, biochemical, microbial, and genetic basis of food allergy. Results of research studies will be correlated with the scope and severity of their clinical phenotype, their response to treatment, and the natural history of their allergic disease(s).

  Eligibility

Ages Eligible for Study:   2 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • GENERAL INCLUSION CRITERIA:

All participants must meet the following criteria:

  1. Be 2 to 99 years-old at the time on enrollment
  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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02504853

Contacts
Contact: Caeden Dempsey (301) 761-7887 caeden.dempsey@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Pamela A Guerrerio, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT02504853     History of Changes
Other Study ID Numbers: 150162
15-I-0162
Study First Received: July 21, 2015
Last Updated: May 9, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Eosinophilic Esophagitis
Loeys-Dietz Syndrome
TGFbeta

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Loeys-Dietz Syndrome
Immune System Diseases
Hypersensitivity, Immediate
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Aortic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 23, 2017