Trial Search Results

Food Allergen OIT for Shrimp and Cashew

A prospective Phase 2, single-center, single-allergen OIT of cashew or shrimp in participants with proven allergies to either cashew or shrimp, respectively. We intend to treat 72 participants, ages 7 to 55 years with an allergy to either cashew, or shrimp determined by Double Blind-Placebo Controlled-Food Challenge (DBPCFC), allergy history, clinical symptoms, food-allergen (FA)-specific IgE levels, and skin prick test (SPT).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Kari Christine Nadeau, MD PhD

Stanford Investigator(s):

Intervention(s):

  • Drug: Cashew or Shrimp Oral Immunotherapy

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Subject and/or parent guardian must be able to understand and provide informed consent

   - Age 7 through 55 years (inclusive)

   - Clinical history of allergy to cashew or shrimp-containing foods

   - Serum IgE to cashew or shrimp of ≥0.35 kUA/L [determined by UniCAPTM within the past
   12 months] and/or a SPT to cashew or shrimp ≥3 mm compared to control

   - Experience dose-limiting symptoms at or before the 300 mg challenge dose of FA protein
   on Screening DBPCFC conducted in accordance with PRACTALL guidelines

   - Written informed consent from adult participants

   - Written informed consent from parent/guardian for minor participants

   - Written assent from minor participants as appropriate (e.g., above the age of 7 years
   or the applicable age per local regulatory requirements)

   - All female subjects of child-bearing potential will be required to provide a blood or
   urine sample for pregnancy testing that must be negative one week before being allowed
   to participate in the study.

   - Use of effective birth control by female participants of child-bearing potential.

Exclusion Criteria:

   - Inability or unwillingness of a participant to give written informed consent or comply
   with study protocol

   - History of uncontrolled cardiovascular disease, including uncontrolled hypertension

   - History of other chronic disease (other than asthma, atopic dermatitis, or allergic
   rhinitis) requiring therapy (e.g., heart disease, diabetes) that is, or is at
   significant risk of becoming unstable or requiring a change in chronic therapeutic
   regimen and, in the opinion of the Principal Investigator, would represent a risk to
   the subject's health or safety in this study or the subject's ability to comply with
   the study protocol.

   - History of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal
   disease, chronic, recurrent, or severe gastroesophageal reflux disease (GERD) grade 3
   according to CTCAE version 5.0, symptoms of dysphagia (e.g., difficulty swallowing,
   food "getting stuck"), or recurrent gastrointestinal symptoms of undiagnosed etiology

   - Current participation in any other interventional study

   - Subject is currently in the build-up phase of immunotherapy to another allergen

   - Severe asthma (NAEPP EPR-3 Medication Criteria Steps 5 or 6)

   - Mild or moderate asthma (NAEPP EPR-3 Medication Criteria Steps 1-4), if not controlled
   as indicated by an ACT<19

   - A hospitalization for asthma in the past 6 months

   - ER visit for asthma within the past 6 months

   - Burst or steroid course for asthma in the past 6 months

   - Use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral
   or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic
   therapy (e.g., infliximab, rituximab, etc.) within the past 6 months

   - Use of complementary and alternative medicine (CAM) treatment modalities (e.g., herbal
   remedies) for atopic and /or non-atopic disease within 90 days preceding Initial Dose
   Escalation Day (IDED) or at any time after the IDED

   - Use of beta-blockers (oral)

   - Pregnancy or lactation

   - Allergy to oat (placebo in DBPCFC)

   - History of severe anaphylaxis to cashew or shrimp with symptoms including hypotension
   requiring fluid resuscitation and/or the need for mechanical ventilation within the
   last year

   - Use of investigational drugs within 12 weeks of participation

   - Past or current medical problems or findings from physical assessment or laboratory
   testing that are not listed above, which, in the opinion of the investigator, may pose
   additional risks from participation in the study, may interfere with the participant's
   ability to comply with study requirements or that may impact the quality or
   interpretation of the data obtained from the study

Ages Eligible for Study

7 Years - 55 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting