Clinical Trial: Walnut Oral Immunotherapy for Tree Nut Allergy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Walnut Oral Immunotherapy for Tree Nut Allergy

Brief Summary: The purpose of this research study is to learn about the medical effects, safety, and how the Walnut Oral Immunotherapy (OIT) treatment affects your body (immune system). This type of immunotherapy involves giving increasing doses of walnut allergen to gradually build up a person's tolerance to walnut and at least one other tree nut. The goal of the study is to determine whether participants can tolerate (eat) walnuts and at least one other tree nut in their diet after stopping the study therapy.

Detailed Summary:

Our central hypothesis is that tree nut allergic subjects with multiple tree nut allergies will experience both clinical desensitization and immunologic evidence of a shift towards tolerance induction to multiple tree nuts when treated with OIT to walnut protein alone. We will address our hypothesis through investigations focused on the following objectives:

Objective #1: Examine the role of specific OIT to walnut protein in the induction of clinical desensitization to other tree nuts.

Objective #2: Determine the role of specific OIT to walnut protein in the induction of clinical desensitization to walnut.

Objective #3: Determine the change in tree nut specific immune parameters associated with OIT related to clinical desensitization and a shift towards oral tolerance.

Primary Objective:

To examine the effectiveness of walnut OIT on clinical desensitization to a second tree nut (designated "test tree nut") causing allergy when compared to placebo treatment. The primary outcome of this objective will be the change from baseline OFC in cumulative dose reached at the desensitization OFC to the test tree nut.

Purpose and expectations:

This objective is designed to test the feasibility and effectiveness of using walnut OIT to desensitize subjects with other tree nut allergy(s). We expect to demonstrate the effectiveness of walnut OIT by showing that subjects on walnut OIT will have negative double-blind placebo-controlled food challenges (DBPCFC) to a second tree nut following completion of a ~38 week course of walnut OIT. We also expect that compared to placebo OIT, walnu
Sponsor: Jonathan Spergel

Current Primary Outcome: effectiveness of walnut immunotherapy on desensitization to test tree nut or reduction in serum specific IgE [ Time Frame: 38 weeks ]

The primary clinical efficacy outcome of the study will be the change from baseline OFC in cumulative dose reached at the desensitization OFC to the test tree nut.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The percentage of subjects who reach a cumulative dose of 5000 mg and 2000 mg at the desensitization OFC to walnut and to the test tree nut (desensitization OFC is at ~38 weeks) [ Time Frame: 38 weeks ]
    1.The percentage of subjects who reach a cumulative dose of 5000 mg and 2000 mg at the desensitization OFC to walnut and to the test tree nut (desensitization OFC is at ~38 weeks)
  • The percentage of subjects who reach a cumulative dose of 5000 mg and 2000 mg at the desensitization OFC to walnut and to the test tree nut (desensitization OFC is at ~38 weeks) [ Time Frame: 38 weeks ]
    2.The percentage of subjects that demonstrate clinical tolerance at end of study to walnut and to the test tree nut.
  • The percentage of subjects who reach a cumulative dose of 5000 mg and 2000 mg at the desensitization OFC to walnut and to the test tree nut (desensitization OFC is at ~38 weeks) [ Time Frame: 38 weeks ]
    3.The change in immune parameters over time including humoral responses, basophil/effector cell responses, and cytokine responses to tree nuts in cultured cells over time.
  • The percentage of subjects who reach a cumulative dose of 5000 mg and 2000 mg at the desensitization OFC to walnut and to the test tree nut (desensitization OFC is at ~38 weeks) [ Time Frame: 38 weeks ]
    4.Incidence of all serious adverse events during the study


Original Secondary Outcome: Same as current

Information By: Children's Hospital of Philadelphia

Dates:
Date Received: April 12, 2013
Date Started: November 2013
Date Completion: February 2016
Last Updated: September 8, 2014
Last Verified: September 2014