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Walnut Oral Immunotherapy for Tree Nut Allergy (WOIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01546753
Recruitment Status : Active, not recruiting
First Posted : March 7, 2012
Last Update Posted : July 9, 2019
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
The purpose of this study is to determine if walnut oral immunotherapy can be used in subjects allergic to tree nuts to reduce tree nut allergy and induce changes in the subject's immune system.

Condition or disease Intervention/treatment Phase
Nut Hypersensitivities Drug: Walnut Protein Powder Drug: Oat Powder (placebo) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Walnut Oral Immunotherapy for Tree Nut Allergy
Actual Study Start Date : April 27, 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Walnut Protein Powder Drug: Walnut Protein Powder
Dosing begins with a one-day walnut oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks), after which the study will be unblinded. Active treatment subjects will continue on maintenance dosing for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.

Placebo Comparator: Oat Powder Drug: Oat Powder (placebo)
Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at ~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein double blind, placebo controlled OFC to walnut and a 5 gram protein OFC to a second tree nut (at ~38 weeks), after which the study will be unblinded. Placebo subjects that fail the OFC will be crossed over to active treatment beginning with initial escalation day.

Primary Outcome Measures :
  1. Effectiveness of walnut oral immunotherapy on clinical desensitization to a second tree nut causing allergy [ Time Frame: 38 weeks of therapy ]
    Determine in tree nut allergic subjects the effectiveness of walnut oral immunotherapy on clinical desensitization to a second tree nut ("test tree nut") causing allergy when compared to placebo treatment, as measured by the change in cumulative dose from baseline oral food challenge (OFC) to the OFC to the test tree nut at approximately 38 weeks on therapy.

Secondary Outcome Measures :
  1. Percentage of subjects who can tolerate a 5000mg oral food challenge to walnut protein following the desensitization phase of the study [ Time Frame: 38 weeks ]
  2. The percentage of subjects reaching a cumulative protein dose of 2000mg at the desensitization oral food challenge to walnut and the test tree nut [ Time Frame: 38 weeks ]
  3. The percentage of subjects demonstrating clinical tolerance at the end of study to walnut and to the test tree nut [ Time Frame: 36 months ]
  4. The change in immune parameters over time [ Time Frame: 36 months ]
    Delineate the impact of walnut OIT on the subsequent cellular and humoral response to walnut protein by the following: 1) analysis of walnut and second tree nut specific IgE, IgG and IgG4 response, 2) characterization of allergen specific basophil activation, 3) characterization of mast cell responses through skin prick testing, and 4) analysis of specific T cell cytokine responses and regulatory T cell activation

  5. Incidence of all serious adverse events during the study [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 6 to 45 years, either sex, any race, any ethnicity with a convincing clinical history of walnut or another tree nut allergy and either a positive prick skin test (> 3mm) or serologic evidence of allergic sensitization (defined as specific IgE > 0.35 kU/L) to walnut and at least one other tree nut.
  • A positive 2000 mg oral food challenge at enrollment to walnut and to one other tree nut.
  • Written informed consent from participant and/or parent/guardian
  • Written assent from all subjects as appropriate
  • All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

  • History of severe anaphylaxis to walnut or other tree nuts, defined as symptoms associated with hypoxia, hypotension or neurologic compromise (cyanosis or SpO2 < 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence).
  • Known allergy to oat
  • Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy or other respiratory or medical conditions deemed by the investigator to put the subject at increased risk of anaphylaxis or poor outcomes from receiving OIT or undergoing food challenge.
  • Poor control or persistent activation of atopic dermatitis
  • Active eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease in the past 2 years.
  • Participation in any interventional study for food allergy in the past 6 months
  • Participant is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing).
  • Severe asthma (2007 NHLBI Criteria Steps 5 or 6, see Appendix 2) or poorly controlled mild or moderate asthma
  • Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
  • 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 within the past year
  • Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
  • Pregnancy or lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01546753

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United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
University of Arkansas
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Principal Investigator: Stacie M Jones, MD University of Arkansas for Medical Sciences / Arkansas Children's Hospital

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Responsible Party: University of Arkansas Identifier: NCT01546753     History of Changes
Other Study ID Numbers: 113364
FAAN ( Other Identifier: Food Allergy and Anaphylaxis Network )
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Keywords provided by University of Arkansas:
Walnut hypersensitivity
Tree nut hypersensitivity
Oral immunotherapy
Food allergy
Walnut allergy
tree nut allergy
Additional relevant MeSH terms:
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Nut Hypersensitivity
Immune System Diseases
Nut and Peanut Hypersensitivity
Food Hypersensitivity
Hypersensitivity, Immediate