This trial is active, not recruiting.

Condition nut hypersensitivities
Treatments walnut protein powder, oat powder (placebo)
Phase phase 1/phase 2
Sponsor University of Arkansas
Start date April 2012
End date April 2020
Trial size 15 participants
Trial identifier NCT01546753, 113364, FAAN


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
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 (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 Outcomes

Effectiveness of walnut oral immunotherapy on clinical desensitization to a second tree nut causing allergy
time frame: 38 weeks of therapy

Secondary Outcomes

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
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
The percentage of subjects demonstrating clinical tolerance at the end of study to walnut and to the test tree nut
time frame: 36 months
The change in immune parameters over time
time frame: 36 months
Incidence of all serious adverse events during the study
time frame: 36 months

Eligibility Criteria

Male or female participants from 6 years up to 45 years old.

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

Additional Information

Official title Walnut Oral Immunotherapy for Tree Nut Allergy
Principal investigator Stacie M Jones, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Arkansas.