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Study of Tolerance to Oral Peanut
DOI 10.1186/ISRCTN62416244
ClinicalTrials.gov identifier
EudraCT number
Public title Study of Tolerance to Oral Peanut
Scientific title Study of Tolerance to Oral Peanut: a randomised controlled trial of oral peanut immunotherapy
Acronym STOP
Serial number at source 7993; EME 08/99/18
Study hypothesis The hypothesis is that peanut oral immunotherapy will result in an increase in tolerance to peanut in peanut-allergic children.

Link to EME project website: http://www.eme.ac.uk/projectfiles/089918info.pdf
Lay summary Not provided at time of registration
Ethics approval MREC approved on the 01/02/2010 (ref: 09/H0308/154)
Study design Randomised interventional treatment trial
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics
Participants - inclusion criteria 1. Aged greater than 7 years, either sex
2. Peanut allergy defined as a clear history of a typical immediate reaction following definite peanut ingestion
Participants - exclusion criteria Major immunodeficiency (this will influence outcome)
Anticipated start date 01/09/2009
Anticipated end date 31/08/2013
Status of trial Completed
Patient information material
Target number of participants Planned Sample Size: 104; UK Sample Size: 104
Interventions There are two work packages:

Package 1:
The active group will undergo oral peanut immunotherapy (OIT - the intervention) and the control group will undergo a waiting list period of current standard management for 5 months. Both groups will then undergo double blind peanut challenge to determine tolerance.

Package 2:
Those subjects in the waiting list control group who are still allergic at the end of the period of standard management will undergo peanut immunotherapy. After active treatment the control group will undergo a final double blind peanut challenge. Peanut oral immunotherpy consists of daily doses of oral peanut flour. The dose increases every 2 weeks according to the schedule: 5, 12, 25, 50, 100, 200, 400, 800 mg peanut protein equivalence.
Primary outcome measure(s) Proportion of subjects in the active and control groups who pass a peanut challenge
Secondary outcome measure(s) 1. Adverse effect of immunotherapy, laboratory assays
Sources of funding Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/99/18)
Trial website
Publications 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24485709
Contact name Dr  Andrew  Clark
  Address Allergy and Clinical Immunology
Box No 40, Addenbrookes Hospital , Hills Road
  City/town Cambridge
  Zip/Postcode CB2 2QQ
  Country United Kingdom
Sponsor Addenbrooke's Hospital (UK)
  Address Addenbrookes Hospital
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 2QQ
  Country United Kingdom
  Sponsor website: http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
Date applied 29/04/2010
Last edited 05/02/2014
Date ISRCTN assigned 29/04/2010
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