Study of Tolerance to Oral Peanut

Phase 1

Completed

• Conditions: Peanut Allergy
• Interventions: Dietary Supplement: Peanut oral immunotherapy

• Registration Number: NCT01259804
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Open pilot study of peanut oral immunotherapy in 22 children with peanut allergy

Detailed Description

Background Peanut allergy is severe and rarely resolves.

Objective To test the efficacy and safety of a new oral immunotherapy protocol for peanut allergy.

Method 22 peanut-allergic children will undergo oral challenge. Oral immunotherapy will be administered by gradual updosing with 2-weekly increments (8-38w) to 800mg protein (5 peanuts/day) followed by 30-weeks maintenance. Oral challenge will be repeated after 6 and 30 weeks maintenance.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-13
• Last Update Posted: 2015-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Peanut allergy defined by oral challenge

Exclusion Criteria

• Major immunodeficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peanut immunotherapy	Peanut oral immunotherapy	Peanut flour

Primary Outcome Measures

Name	Time	Method
Pass/fail peanut challenge	six months

Trial Locations

Locations (1)

Cambridge Biomedical Campus; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom