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NCT02504853 · National Institute of Allergy and Infectious Diseases (NIAID)

Natural History and Genetics of Food Allergy and Related Conditions

What this study is about

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.

View original scientific 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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • 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 ADDITIONAL INCLUSION CRITERIA FOR AFFECTED PARTICIPANTS 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. ADDITIONAL INCLUSION CRITERIA FOR UNAFFECTED RELATIVES: 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 ADDITIONAL INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS 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 ADDITIONAL PROCEDURE- SPECIFIC INCLUSION CRITERIA: The following additional inclusion criteria apply for participants undergoing leukapheresis:
  • Age \>= 18 years
  • Stable hematologic parameters (definition: white blood cell count \> 2,500/microL, hemoglobin \> 10 g/dL, and platelet count \> 75,000/microL) 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 unaffected relatives and healthy volunteers who are undergoing endoscopy with biopsies for research purposes. Unaffected relatives and healthy volunteers will be excluded from participating in this procedure if they meet any of the following criteria:
  • uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist s Physical Status Classification System (https://journals.lww.com/anesthesiologyopen/fulltext/2026/04000/american\_society\_of\_anesthesiologists\_statement\_on.2.aspx)
  • 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

Where

  • Bethesda, Maryland

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 1, 2026 · Source of record for eligibility and locations

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Study locations

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RECRUITING

Bethesda

Maryland

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Food Allergy Treatment in Bethesda?

Join others in Maryland exploring innovative treatment options through clinical research

Food Allergy Treatment Options in Bethesda, Maryland

If you're searching for Food Allergy treatment in Bethesda, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Bethesda and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Food Allergy. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Maryland
Now Enrolling
Up to 1800 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Food Allergy?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Food Allergy

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Food Allergy Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT02504853. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.