Induction of tolerance through early introduction of peanut in high-risk children
| ISRCTN | ISRCTN94818122 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94818122 |
| ClinicalTrials.gov number | NCT00329784 |
| Secondary identifying numbers | ITN032AD Lack |
- Submission date
- 19/12/2006
- Registration date
- 04/04/2007
- Last edited
- 29/01/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
The number of children in the Western World that have a peanut allergy has doubled in the past ten years and the allergy is now also found in Africa and Asia. It is the leading course of food allergy related anaphylaxis (acute allergic reaction) and death. The allergy develops early in life and is generally life-long. Studies have suggested that the earlier peanuts are introduced to a childs diet, the less likely they are to develop an allergy to them. This study looks at whether giving children that are considered at higher risk of developing a peanut allergy (as they are already allergic to eggs or have severe eczema) earlier in life reduces the risk of them actually becoming allergic to peanuts.
Who can participate?
Children aged between 4 months and 11 months that have an egg allergy, severe eczema, or both.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are fed a peanut-containing snack-food at least three times each week until they are 5 years old. Those in the second group avoid eating food containing peanuts until they are 5 years old. All the children are followed up to see which ones develop a peanut allergy.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Evelina Children's Hospital, London (UK)
When is the study starting and how long is it expected to run for?
November 2006 to July 2013
Who is funding the study?
1. US National Institute of Allergy & Infectious Diseases
2. Immune Tolerance Network (USA)
3. Food Allergy Initiative (USA)
4. Food Standards Agency (UK)
Who is the main contact?
Professor Gideon Lack
info@leapstudy.co.uk
Contact information
Scientific
Evelina Children's Hospital
Guy's & St. Thomas' NHS Foundation Trust
Lambeth Palace Road
London
SE1 7EH
United Kingdom
| Phone | +44 (0)20 7188 9784 |
|---|---|
| info@leapstudy.co.uk |
Study information
| Study design | Randomised controlled single-site trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Patient information can be found at: http://www.leapstudy.co.uk/participating.html |
| Scientific title | Induction of tolerance through early introduction of peanut in high-risk children |
| Study acronym | LEAP (Learning Early About Peanut allergies) |
| Study hypothesis | This study will evaluate whether early avoidance or exposure to peanuts promotes tolerance and provides protection from developing peanut allergy in children who are at high risk as determined by allergy to eggs or severe eczema. |
| Ethics approval(s) | St. Marys Research Ethics Committee, 23/10/2006, ref: 04/Q0413/13 |
| Condition | Peanut allergy, peanut hypersensitivity, eczema, egg hypersensitivity, food hypersensitivity |
| Intervention | Participants assigned to the peanut consumption group will be fed at least 6 g of peanut protein per week, distributed over at least three meals per week during study participation. The preferred peanut source will be Bamba, however, peanut butter may be substituted. Participants assigned to the peanut avoidance group will avoid exposure to peanut protein during study participation. |
| Intervention type | Supplement |
| Primary outcome measure | The proportion of participants with peanut allergy at 60 months of age. |
| Secondary outcome measures | 1. Effect of peanut consumption on other allergy outcomes 2. Safety of peanut consumption among study participants 3. Immunologic mechanisms by which consumption of peanut may induce tolerance to peanuts |
| Overall study start date | 29/11/2006 |
| Overall study end date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Months |
| Upper age limit | 11 Months |
| Sex | Both |
| Target number of participants | 480 |
| Participant inclusion criteria | 1. Children greater than four months and less than 11 months of age 2. Have had solid foods introduced successfully into their diet 3. Egg allergy, severe eczema or both |
| Participant exclusion criteria | 1. Clinically significant chronic illness, except for eczema or recurrent wheeze 2. Positive skin prick test for peanut allergen with a wheal diameter of greater than 4 mm 3. Previous or current consumption of peanut 4. Previous allergic reaction to peanut 5. Sibling or other household member who is allergic to peanut 6. Certain other immunological criteria |
| Recruitment start date | 29/11/2006 |
| Recruitment end date | 01/07/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 7EH
United Kingdom
Sponsor information
Government
185 Berry Street
Suite 3515
San Francisco
94107
United States of America
| Phone | +1 415 353 4418 |
|---|---|
| nnasser@immunetolerance.org | |
| Website | http://www.immunetolerance.org |
"ROR" |
https://ror.org/043z4tv69 |
Funders
Funder type
Government
No information available
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- FAI
- Location
- United States of America
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Food Standards Agency, FSA
- Location
- United Kingdom
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 | 26/02/2015 | Yes | No |
Editorial Notes
29/01/2016: Publication reference added
