Overview

This trial is active, not recruiting.

Condition food hypersensitivity
Treatments peanut slit, placebo slit
Sponsor University of North Carolina, Chapel Hill
Start date January 2008
End date June 2016
Trial size 33 participants
Trial identifier NCT00597727, 11-2296

Summary

The specific aim of this study is to determine if peanut allergen-specific SLIT will cause clinical desensitization and tolerance to develop in peanut-allergic young children.

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)
Primary purpose treatment
Arm
(Active Comparator)
Subjects who receive the protein (peanut sublingual drops) at the beginning of the study.
peanut slit Sublingual peanut protein drops
Liquid peanut protein drops diluted in glycerin which are dosed under the tongue.
(Placebo Comparator)
Subjects who receive placebo (glycerin sublingual drops) at the beginning of the study.
placebo slit Sublingual glycerin saline drops
Liquid glycerin without peanut which are dosed under the tongue.

Primary Outcomes

Measure
Determine if peanut-specific SLIT will cause clinical desensitization to develop in peanut-allergic young children.
time frame: 12 months

Secondary Outcomes

Measure
Determine if peanut-specific SLIT will cause tolerance to develop in peanut-allergic young children.
time frame: baseline and at least annually up to 68 months
Determine if the development of the desensitized state and tolerance to peanut is associated with the down-regulation of mast cells and basophils.
time frame: baseline and at least annually up to 68 months
Determine the effect of peanut-specific mucosal and systemic humoral immune responses on oral tolerance and peanut SLIT.
time frame: baseline and at least annually up to 68 months
Delineate the mechanism of the T-cell response to allergen-specific T-cells during peanut SLIT - (regulatory T cells).
time frame: baseline and at least annually up to 68 months
Delineate the mechanism of the T-cell response to allergen-specific T-cells during peanut SLIT - (TH2/TH1 cytokines).
time frame: baseline and at least annually up to 68 months
Delineate the mechanism of the T-cell response to allergen-specific T-cells during peanut SLIT - (oligonucleotide microarrays).
time frame: baseline and at least annually up to 68 months

Eligibility Criteria

Male or female participants from 1 year up to 11 years old.

Inclusion Criteria: - Peanut IgE > 7kU/L (> 2kU/L for children aged 2 years and under) AND - History of significant clinical symptoms within 60 minutes after the ingestion of peanuts. Exclusion Criteria: - History of severe life-threatening anaphylaxis to peanut, OR - Medical history that would prevent a DBPCFC to peanut, OR - Subjects with wheat or oat allergy (which are used in the placebo), OR - Unable to cooperate with challenge procedures, OR - Unable to be reached by telephone for follow-up

Additional Information

Official title A Double-blinded, Placebo-controlled Study of Peanut Sublingual Immunotherapy in Children - DBPC Peanut SLIT
Principal investigator Wesley Burks, MD
Description In spite of increased recognition and understanding of food allergies, food-induced anaphylaxis remains the single most common cause of anaphylaxis seen in hospital emergency departments, accounting for about one third of anaphylaxis cases seen. It is estimated that about 30,000 food-induced anaphylactic events are seen in U.S. emergency departments each year and that about 200 fatal cases occur in the U.S. each year. Either peanuts or tree nuts cause more than 80% of these reactions. No treatments are available and avoidance is the only approved intervention. The goal of this study is to investigate peanut sublingual immunotherapy (SLIT) as a treatment for children with peanut allergy. This study is designed to evaluate the efficacy and safety of peanut SLIT compared to placebo after 12 months. Mechanistic studies will be completed concurrently to understand changes in the allergic immune response related to peanut SLIT. The remainder of the study is designed to evaluate the efficacy of peanut SLIT in inducing lasting tolerance after discontinuation of the peanut SLIT.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill.