Oral Immunotherapy for Peanut Allergy (PMIT)

NCT ID: NCT00597675

Last Updated: 2018-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2014-06-30

Brief Summary

The purpose of this study is to determine if mucosal peanut immunotherapy will make subjects who have peanut allergy less allergic and induce changes in their immune system.

Detailed Description

Peanut allergy is known to cause severe anaphylactic reactions. Compared with other food allergies it tends to be more persistent and also its prevalence seems to be rising. Currently there is no proven treatment other than strict avoidance. We are attempting to decrease the risk of anaphylaxis on accidental ingestion by desensitizing subjects to peanut using peanut oral mucosal immunotherapy (OIT). We are also studying the effect of peanut OIT on the peanut specific immune response to determine if tolerance to peanut protein will develop. Children ages 1 to 18 with peanut allergy will be randomized to peanut OIT or placebo. Subjects will undergo a modified rush immunotherapy on the first day and then increase the doses at least every two weeks up to a maintenance dose of 4 grams (equivalent to about 13 peanuts). Doses will be taken daily at home except for dose increases which will be done on the research unit. Subjects will undergo a double-blind, placebo-controlled food challenge (DBPCFC) after 12 months and then be unblinded. Placebo subjects will cross over to open-label peanut OIT and undergo an identical buildup schedule up to 12 months. All subjects will then complete at least 36 months of peanut OIT therapy after which once skin prick (<5 mm) and IgE (<15 kU/L) criteria are met, they will then complete the end of study DBPCFC. Dosing will continue up to a maximum of 60 months after which even if criteria are not met, the subject will undergo the end of study DBPCFC. Outcome variables of interest include response to DBPCFC, skin prick testing, peanut specific IgE, and adverse events. These results will be compared between the start and end of peanut OIT using appropriate statistical analysis.

Conditions

Food Hypersensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Oat flour ingested daily as a placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

Oat flour matched by weight and consistency that is ingested daily as a placebo

Peanut OIT

Peanut flour ingested daily as oral mucosal immunotherapy

Group Type: ACTIVE_COMPARATOR

Peanut OIT

Intervention Type: BIOLOGICAL

Defatted peanut flour ingested daily as oral mucosal immunotherapy

Interventions

Peanut OIT

Defatted peanut flour ingested daily as oral mucosal immunotherapy

Intervention Type: BIOLOGICAL

Placebo

Oat flour matched by weight and consistency that is ingested daily as a placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subject between 1 and 18 years of age
• EITHER history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts greater than 6 months ago AND peanut specific IgE >15 kU/L
• OR history of significant clinical symptoms occurring within 60 minutes after ingesting peanuts within the past 6 months AND peanut specific IgE > 7 kU/L
• A family that will be able to be compliant with all study visits
• All females of child bearing age must be using appropriate birth control

Exclusion Criteria

• Subjects with a history of severe, anaphylaxis to peanut
• Medical history that would prevent a double blind placebo controlled oral food challenge (DBPCFC/OFC) to peanut
• Unable to cooperate with challenge procedures or unable to be reached by telephone for follow-up
• Diagnosed oat allergy
• Pregnancy or lactation

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arvil W Burks, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of Arkansas Medical Center

Little Rock, Arkansas, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

Pro00000163

Identifier Type: -

Identifier Source: org_study_id