Study of Tolerance to Oral Peanut
| ISRCTN | ISRCTN62416244 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62416244 |
| Protocol serial number | 7993; EME 08/99/18 |
| Sponsor | Addenbrooke's Hospital (UK) |
| Funder | Medical Research Council (MRC)/National Institutes of Health Research (NIHR) (UK) - Efficacy and Mechanism Evaluation (EME) Programme (ref: 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 of protocol
Not provided at time of registration
Contact information
Dr Andrew Clark
Scientific
Scientific
Allergy and Clinical Immunology
Box No 40
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Study of Tolerance to Oral Peanut: a randomised controlled trial of oral peanut immunotherapy |
| Study acronym | STOP |
| Study objectives | 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) |
| Health condition(s) or problem(s) studied | 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(s) | Proportion of subjects in the active and control groups who pass a peanut challenge |
| Key secondary outcome measure(s) | 1. Adverse effect of immunotherapy, laboratory assays |
| Completion date | 31/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Not Specified |
| Target sample size at registration | 104 |
| Key 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 |
| Key exclusion criteria | Major immunodeficiency (this will influence outcome) |
| Date of first enrolment | 01/09/2009 |
| Date of final enrolment | 31/08/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Addenbrookes Hospital
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
