Condition category
Injury, Occupational Diseases, Poisoning
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
03/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Clark

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7993; EME 08/99/18

Study information

Scientific title

Study of Tolerance to Oral Peanut: a randomised controlled trial of oral peanut immunotherapy

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

MREC approved on the 01/02/2010 (ref: 09/H0308/154)

Study design

Randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/09/2009

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Other

Gender

Not Specified

Target number of participants

Planned Sample Size: 104; UK Sample Size: 104

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

United Kingdom

Trial participating centre

Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Addenbrooke's Hospital (UK)

Sponsor details

Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24485709
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25642539

Publication citations

  1. Results

    Anagnostou K, Islam S, King Y, Foley L, Pasea L, Bond S, Palmer C, Deighton J, Ewan P, Clark A, Assessing the efficacy of oral immunotherapy for the desensitisation of peanut allergy in children (STOP II): a phase 2 randomised controlled trial., Lancet, 2014, 383, 9925, 1297-1304, doi: 10.1016/S0140-6736(13)62301-6.

  2. Results

    Anagnostou K, Islam S, King Y, Foley L, Pasea L, Palmer C, Bond S, Ewan P, Clark A, Study of induction of Tolerance to Oral Peanut: a randomised controlled trial of desensitisation using peanut oral immunotherapy in children (STOP II).

Additional files

Editorial Notes