Condition category
Injury, Occupational Diseases, Poisoning
Date applied
19/12/2006
Date assigned
04/04/2007
Last edited
29/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

http://www.leapstudy.co.uk

Contact information

Type

Scientific

Primary contact

Prof Gideon Lack

ORCID ID

Contact details

Evelina Children's Hospital
Guy's & St. Thomas' NHS Foundation Trust
Lambeth Palace Road
London
SE1 7EH
United Kingdom
+44 (0)20 7188 9784
info@leapstudy.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00329784

Protocol/serial number

ITN032AD Lack

Study information

Scientific title

Induction of tolerance through early introduction of peanut in high-risk children

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

St. Mary’s Research Ethics Committee, 23/10/2006, ref: 04/Q0413/13

Study design

Randomised controlled single-site trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Patient information can be found at: http://www.leapstudy.co.uk/participating.html

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

Phase

Drug names

Primary outcome measures

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 trial start date

29/11/2006

Overall trial end date

01/07/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

480

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

United Kingdom

Trial participating centre

Evelina Children's Hospital
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Immune Tolerance Network for National Institute of Allergy and Infectious Diseases

Sponsor details

185 Berry Street
Suite 3515
San Francisco
94107
United States of America
+1 415 353 4418
nnasser@immunetolerance.org

Sponsor type

Government

Website

http://www.immunetolerance.org

Funders

Funder type

Government

Funder name

US National Institute of Allergy & Infectious Diseases

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Immune Tolerance Network (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Food Allergy Initiative

Alternative name(s)

FAI

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United States of America

Funder name

Food Standards Agency

Alternative name(s)

FSA

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2015 results in http://www.ncbi.nlm.nih.gov/pubmed/25705822

Publication citations

Additional files

Editorial Notes

29/01/2016: Publication reference added