Bethesda, MDNCT02504853Now EnrollingIRB Ready

Food Allergy Clinical Trial in Bethesda, MD

Access cutting-edge food allergy treatment through this clinical trial at a research site in Bethesda. Study-provided care at no cost to qualified participants.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

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Expert Care in Bethesda

Access food allergy specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related food allergy treatment provided free

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Check if you qualify for this food allergy clinical trial in Bethesda, MD

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Why Participate?

  • No-Cost Study Care

  • Local to Bethesda

    Convenient for MD residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Bethesda site if eligible
  4. 4Begin participation

About This Food Allergy Study in Bethesda

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.

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

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Bethesda?

Yes, this clinical trial (NCT02504853) has an active research site in Bethesda, MD that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Food Allergy Treatment Options in Bethesda, MD

If you're searching for food allergy treatment options in Bethesda, MD, this clinical trial (NCT02504853) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Bethesda research site is actively enrolling participants for this clinical trial. You'll receive care from experienced food allergy specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all food allergy clinical trials near you to find additional studies recruiting in your area.

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