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| [ Print-friendly version ] |
| EAT Trial - Early introduction of allergenic foods to induce tolerance in infants |
| ISRCTN | ISRCTN14254740 |
| DOI | 10.1186/ISRCTN14254740 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | EAT Trial - Early introduction of allergenic foods to induce tolerance in infants |
| Scientific title | Randomised controlled trial of early introduction of allergenic foods to induce tolerance in infants |
| Acronym | EAT (Enquiring About Tolerance) |
| Serial number at source | FSA ref: T07051 |
| Study hypothesis |
1. The early introduction of allergenic foods (from three months of age) will induce regulatory mechanisms that result in a reduced level of food allergy by three years of age. The effect on food sensitisation at three years of age will be determined.
2. The early introduction (from three months of age) of allergenic foods into the infant's diet may lead to a reduction in the prevalence of other allergic conditions by three years of age: specifically asthma (including atopic wheeze), eczema, allergic rhinitis (including aero-allergen sensitisation) combined food allergy prevalence (including food sensitization) and the prevalence of combined allergic disease. 3. The early introduction of allergenic foods does not have any deleterious effects |
| Lay summary | |
| Ethics approval | St Thomas' Hospital Research Ethics Committee, approved on 20/10/2008 (ref: 08/H0802/93) |
| Study design | Randomised controlled multi-centre trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Food allergy, food hypersensitivity, eczema, asthma, allergic rhinitis |
| Participants - inclusion criteria |
1. Pregnant mothers attending their 12/20 week ultrasound scans
2. Mothers planning on exclusively breast feeding for at least the first 3 months 3. Informed consent obtained from parent or guardian |
| Participants - exclusion criteria |
1. Significant antenatal anomaly at 20 week ultrasound scan
2. Multiple pregnancy 3. Significant congenital disease (enteropathy, congenital heart disease, renal disease) 4. Premature delivery (less than 37 completed weeks gestation) 5. Parents not planning on breast feeding exclusively for at least the first 3 months 6. Parents planning on moving away from London before their child is three years of age 7. Parents unable to speak and read English 8. Unwillingness or inability to comply with study requirements and procedures 9. Family intend infant to be on a restricted diet (any of the six intervention foods) |
| Anticipated start date | 02/02/2009 |
| Anticipated end date | 31/07/2014 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 3,000 pregnant women (2,500 infants) |
| Interventions |
The intervention arm consists of the dietetic controlled introduction of allergenic foods from three months of age. Baby rice mixed with breast milk or water will be commenced first, followed by cow's milk based yoghurt. Subsequently egg, wheat, sesame, fish and peanut will be sequentially introduced into the diet in high doses with each food being ingested 2 times a week achieving a total ingestion of 4 g or more per week of each food protein by five months of age.
Mothers will not introduce wheat before 4 months of age. Infants in the intervention arm will be required to consume the allergenic foods until the one-year assessment at which point ongoing consumption of all six allergenic foods will be encouraged until the end of the study when subsequent consumption will be a matter of parental choice. The control arm will follow standard UK Government weaning advice (exclusive breast feeding until around 6 months of age) and no early introduction of allergenic foods (egg, wheat, peanuts, tree nuts, seeds, fish and shell fish) before six months of age. Total duration of follow-up: Infant: from 3 months to 3 years of age Joint/Secondary sponsor details: King's College London Room 1.8 Hodgkin Building, Guy's Campus King's College London London, SE1 1UL United Kingdom |
| Primary outcome measure(s) | The period prevalence of IgE mediated food allergy to the six intervention foods between one and three years of age in both arms |
| Secondary outcome measure(s) |
1. Period (one to three years of age) prevalence food outcomes:
1.1. The period prevalence of all IgE mediated food allergy between one and three years of age in both arms 1.2. The period prevalence of all food allergy (IgE and non-IgE mediated) between one and three years of age in both arms 1.3. The period prevalence of sensitisation to food between one and three years of age in both arms 2. Cumulative (by three years of age) prevalence food outcomes: 2.1. The cumulative prevalence of IgE mediated food allergy to the six intervention foods by three years of age. 2.2. The cumulative prevalence of all IgE mediated food allergy by three years of age 2.3. The cumulative prevalence of all food allergy (IgE and non-IgE mediated) by three years of age 2.4. The cumulative prevalence of non-IgE mediated food allergy by three years of age 2.5. The cumulative prevalence of sensitization to the six foods by three years of age 3. Other allergic disease outcomes: 3.1. The point prevalence of eczema at one year and three years of age and cumulative prevalence of eczema by three years of age 3.2. The severity of eczema at one year and three years of age by Severity Scoring of Atopic Dermatitis index (SCORAD) and Nottingham Eczema Severity Score (NESS) 3.3. The prevalence of allergic rhinitis at three years of age 3.4. The prevalence of inhalant allergen sensitisation at one year and at three years of age by skin prick test 3.5. The prevalence of inhalant allergen sensitisation at one year and at three years of age by specific IgE measurement 3.6. The prevalence of the atopic wheeze phenotype at three years of age 4. Composite allergy outcome: 4.1. The prevalence of combined allergic disease (a composite of cumulative IgE mediated food allergy to all foods, atopic wheeze phenotype, eczema and allergic rhinitis) at three years of age 4.2. The prevalence of combined allergic disease (a composite of cumulative IgE and non-IgE mediated food allergy to all foods, atopic wheeze phenotype, eczema and allergic rhinitis) at three years of age |
| Sources of funding |
1. Food Standards Agency (UK) - Lead funder
2. Medical Research Council (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Gideon Lack |
| Address |
Children's Allergies Department
2nd Floor, Stairwell B, South Wing St Thomas' Hospital Lambeth Palace Road |
| City/town | London |
| Zip/Postcode | SE1 7EH |
| Country | United Kingdom |
| Sponsor | Guy's and St Thomas' Foundation NHS Trust (UK) |
| Address |
R&D Department
3rd Floor, Conybeare House Great Maze Pond |
| City/town | London |
| Zip/Postcode | SE1 9RT |
| Country | United Kingdom |
| Sponsor website: | http://www.guysandstthomas.nhs.uk/ |
| Date applied | 06/02/2009 |
| Last edited | 29/07/2009 |
| Date ISRCTN assigned | 31/03/2009 |
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