Study of Tolerance to Oral Peanut (STOP)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of High-dose Peanut Oral Immunotherapy With Factors Predicting Outcome|
- Pass/fail peanut challenge [ Time Frame: six months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Peanut immunotherapy
Dietary Supplement: Peanut oral immunotherapy
Daily doses of peanut flour
Other Name: Daily doses peanut flour
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259804
|Cambridge Biomedical Campus|
|Cambridge, Cambridgeshire, United Kingdom, CB23 7DS|
|Principal Investigator:||Andrew T Clark, MB BD MD||Cambridge Biomedical Campus|