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Walnut Oral Immunotherapy for Tree Nut Allergy (WOIT)

Primary Purpose

Nut Hypersensitivities

Status

Withdrawn

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Walnut Protein Flour

Oat flour

About this trial

This is an interventional treatment trial for Nut Hypersensitivities focused on measuring Walnut hypersensitivity, Tree nut hypersensitivity

Eligibility Criteria

6 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Walnut protein flour

Oat flour

Arm Description

Walnut protein flour that is ingested in gradually increasing amounts up to a maintenance dose.

Oat flour administered in identical increasing amounts as the active walnut protein flour.

Outcomes

Primary Outcome Measures

Effectiveness of walnut oral immunotherapy (WOIT) on clinical desensitization to a second tree nut.

The determination of the effectiveness of WOIT in inducing clinical desensitization to a second tree nut to which the subject is allergic when compared to placebo. This will be measured by the change in the amount of tree nut the subject can consume during their food challenge at 38 weeks compared to their consumption during the baseline challenge at study entry.

Secondary Outcome Measures

Percentage of subjects who can tolerate a 5000mg oral food challenge to walnut protein following the desensitization phase of the study

The percentage of subjects who can consume all of the 5000mg of walnut protein without symptoms during the food challenge after the desensitization phase of the study.

The percentage of subjects who are able to reach a cumulative protein dose of 2000mg at the desensitization oral food challenge to walnut and the test tree nut.

The percentage of subjects who are able to consume a cumulative protein dose of 2000 mg of walnut and test tree nut without symptoms during the desensitization oral food challenge.

The percentage of subjects who demonstrate clinical tolerance at the end of the study to walnut and the test tree nut.

The percentage of subjects who are able to demonstrate clinical tolerance by consuming all of the walnut and test tree nut without symptoms during the oral food challenge at the end of the study.

Full Information

NCT ID

NCT01834352

First Posted

April 12, 2013

Last Updated

June 16, 2016

Sponsor

University of North Carolina, Chapel Hill

1. Study Identification

Unique Protocol Identification Number

NCT01834352

Brief Title

Walnut Oral Immunotherapy for Tree Nut Allergy

Acronym

WOIT

Official Title

Walnut Oral Immunotherapy for Tree Nut Allergy

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Concern for cross contamination in weighing tree nuts in facility with peanuts

Study Start Date

November 2013 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if walnut oral immunotherapy can be used in subjects allergic to tree nuts to decrease their tree nut allergy and induce changes in their immune system.

Detailed Description

Tree nut

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nut Hypersensitivities

Keywords

Walnut hypersensitivity, Tree nut hypersensitivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Walnut protein flour

Arm Type

Active Comparator

Arm Description

Walnut protein flour that is ingested in gradually increasing amounts up to a maintenance dose.

Arm Title

Oat flour

Arm Type

Placebo Comparator

Arm Description

Oat flour administered in identical increasing amounts as the active walnut protein flour.

Intervention Type

Drug

Intervention Name(s)

Walnut Protein Flour

Other Intervention Name(s)

Walnut OIT

Intervention Description

Daily ingestion of gradually increasing amounts of walnut protein flour in order to induce desensitization to walnut and an unrelated tree nut.

Intervention Type

Drug

Intervention Name(s)

Oat flour

Other Intervention Name(s)

Placebo

Intervention Description

Oat flour that is administered as a placebo in identical increasing doses as the active walnut flour treatment.

Primary Outcome Measure Information:

Title

Effectiveness of walnut oral immunotherapy (WOIT) on clinical desensitization to a second tree nut.

Description

Time Frame

38 weeks

Secondary Outcome Measure Information:

Title

Percentage of subjects who can tolerate a 5000mg oral food challenge to walnut protein following the desensitization phase of the study

Description

The percentage of subjects who can consume all of the 5000mg of walnut protein without symptoms during the food challenge after the desensitization phase of the study.

Time Frame

38 weeks

Title

The percentage of subjects who are able to reach a cumulative protein dose of 2000mg at the desensitization oral food challenge to walnut and the test tree nut.

Description

The percentage of subjects who are able to consume a cumulative protein dose of 2000 mg of walnut and test tree nut without symptoms during the desensitization oral food challenge.

Time Frame

38 weeks

Title

The percentage of subjects who demonstrate clinical tolerance at the end of the study to walnut and the test tree nut.

Description

The percentage of subjects who are able to demonstrate clinical tolerance by consuming all of the walnut and test tree nut without symptoms during the oral food challenge at the end of the study.

Time Frame

36 months

Other Pre-specified Outcome Measures:

Title

Increase in walnut and test tree nut IgG4 over the course of the study.

Description

The increase in the walnut and test tree nut specific IgG4 over the course of the study as an indication of the impact of WOIT on the immune system.

Time Frame

36 months

Title

Decrease in the walnut and test tree nut specific IgE over the course of the study.

Description

The decrease in the walnut and test tree nut specific IgE over the course of the study as an indication of the impact of WOIT on the immune system.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wesley Burks, MD

Organizational Affiliation

UNC Chapel Hill

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Edwin Kim, MD

Organizational Affiliation

UNC Chapel Hill

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21093029

Citation

Kulis M, Li Y, Lane H, Pons L, Burks W. Single-tree nut immunotherapy attenuates allergic reactions in mice with hypersensitivity to multiple tree nuts. J Allergy Clin Immunol. 2011 Jan;127(1):81-8. doi: 10.1016/j.jaci.2010.09.014. Epub 2010 Nov 18.

Results Reference

background

PubMed Identifier

19477496

Citation

Hofmann AM, Scurlock AM, Jones SM, Palmer KP, Lokhnygina Y, Steele PH, Kamilaris J, Burks AW. Safety of a peanut oral immunotherapy protocol in children with peanut allergy. J Allergy Clin Immunol. 2009 Aug;124(2):286-91, 291.e1-6. doi: 10.1016/j.jaci.2009.03.045. Epub 2009 May 27.

Results Reference

background

PubMed Identifier

19577283

Citation

Jones SM, Pons L, Roberts JL, Scurlock AM, Perry TT, Kulis M, Shreffler WG, Steele P, Henry KA, Adair M, Francis JM, Durham S, Vickery BP, Zhong X, Burks AW. Clinical efficacy and immune regulation with peanut oral immunotherapy. J Allergy Clin Immunol. 2009 Aug;124(2):292-300, 300.e1-97. doi: 10.1016/j.jaci.2009.05.022. Epub 2009 Jul 3.

Results Reference

background

PubMed Identifier

21377034

Citation

Varshney P, Jones SM, Scurlock AM, Perry TT, Kemper A, Steele P, Hiegel A, Kamilaris J, Carlisle S, Yue X, Kulis M, Pons L, Vickery B, Burks AW. A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response. J Allergy Clin Immunol. 2011 Mar;127(3):654-60. doi: 10.1016/j.jaci.2010.12.1111.

Results Reference

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Walnut Oral Immunotherapy for Tree Nut Allergy

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