Study of Tolerance to Oral Peanut

ISRCTN	ISRCTN62416244
DOI	https://doi.org/10.1186/ISRCTN62416244
Secondary identifying numbers	7993; EME 08/99/18

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 03/02/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Andrew Clark
Scientific

Allergy and Clinical Immunology
Box No 40
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Study information

Study design	Randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Study of Tolerance to Oral Peanut: a randomised controlled trial of oral peanut immunotherapy
Study acronym	STOP
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
Ethics approval(s)	MREC approved on the 01/02/2010 (ref: 09/H0308/154)
Condition	Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Paediatrics
Intervention	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.
Intervention type	Other
Primary outcome measure	Proportion of subjects in the active and control groups who pass a peanut challenge
Secondary outcome measures	1. Adverse effect of immunotherapy, laboratory assays
Overall study start date	01/09/2009
Overall study end date	31/08/2013

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Not Specified
Target number of participants	Planned Sample Size: 104; UK Sample Size: 104
Participant 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
Participant exclusion criteria	Major immunodeficiency (this will influence outcome)
Recruitment start date	01/09/2009
Recruitment end date	31/08/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Addenbrookes Hospital

Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Addenbrooke's Hospital (UK)
Hospital/treatment centre

Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
England
United Kingdom

Website	http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
"ROR"	https://ror.org/055vbxf86

Funders

Funder type

Government

Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: EME 08/99/18)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	12/04/2014		Yes	No
Results article	results	01/12/2014		Yes	No