Trial Search Results

The Peanut Oral Immunotherapy Study: Safety, Efficacy and Discovery

Determine whether peanut oral immunotherapy (OIT) induces clinical tolerance as assessed after the initial 3 month avoidance period

Secondary Objectives:

- Identify the basic immune mechanisms which can explain the differences in the effects of OIT in desensitized vs. tolerant individuals.

- Determine whether immune monitoring measurements reflecting underlying mechanisms during OIT can be used to predict responses to OIT in individual subjects and, ultimately, to improve the safety and efficacy outcomes in peanut OIT protocols.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

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

Stanford Investigator(s):

Intervention(s):

  • Drug: Peanut Protein 4,000mg
  • Drug: Oat Flour
  • Drug: Peanut Protein 300 mg

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Subject and/or parent guardian must be able to understand and provide informed consent
   and/or assent as applicable.

   - Peanut-allergic subjects between the ages of 8-55 years old.

   - Sensitivity to peanut allergen as documented by a positive skin prick test result (5
   mm or greater diameter wheal relative to negative control) within 10 months preceding
   enrollment.

   - Allergy to peanut based on a double-blind placebo-controlled oral food challenge
   (DBPCFC) (see Appendix 4 for scoring details) failed at a dose ≤500 mg with peanut
   protein within 10 months preceding enrollment.

   - 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.

   - Subjects must plan to remain in the study area during the trial.

   - Subjects must be trained on the proper use of the EpiPen (see Appendix 6) to be
   allowed to enroll in the study.

   - Subjects with other food allergies must agree to eliminate these other food items from
   their diet so as not to confound the safety and efficacy data from the study.

   - Use of birth control by female subjects of child-bearing potential

Exclusion Criteria:

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

   - History of cardiovascular disease

   - History of other chronic disease (other than asthma, atopic dermatitis, or rhinitis)
   requiring therapy (e.g., heart disease, diabetes) that, 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 gastrointestinal disease

   - Current participation in any other interventional study

   - Subject is on 'build-up phase" of immunotherapy to another allergen (i.e., has not
   reached maintenance dosing)

   - Severe asthma (2007 NHLBI Criteria Steps 5 or 6) at time of enrollment

   - • 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

   - Inability to discontinue antihistamines for the initial day of escalation, skin
   testing or OFCs

   - Use of omalizumab within the past six months, or current use of other non-traditional
   forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy
   (not including corticosteroids)

   - Use of β-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors,
   angiotensin-receptor blockers (ARB) or calcium channel blockers

   - Pregnancy or lactation

   - History of sensitivity to oat

   - History of severe anaphylaxis to peanut with symptoms including hypotension requiring
   fluid resuscitation and/or the need for mechanical ventilation

   - Use of investigational drugs within 24 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

8 Years - 55 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting