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Walnut Oral Immunotherapy for Tree Nut Allergy

NCT01918657 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-09-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

walnut powder

Subjects will be randomized in a 2:1 ratio into either an active treatment group (final dose 1500 mg walnut protein, n=20) or a placebo group (n=10). Subjects will undergo a one-day desensitization protocol designed to enable the subject to tolerate 6 mg of walnut protein or placebo (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of walnut protein or placebo, dosing build-up will occur every two weeks through dose 24 at 34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein 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 and escalated as described to the 1500 mg target dose.

DRUG

walnut powder

escalating doses of walnut powder

Sponsors & Collaborators

  • University of Arkansas

    collaborator OTHER

  • Jonathan Spergel

    lead OTHER

Principal Investigators

  • Jonathan M Spergel, MD, PhD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01918657 on ClinicalTrials.gov