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Early introduction of allergenic foods to induce tolerance in infants

Randomised controlled trial of early introduction of allergenic foods to induce tolerance in infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14254740
Enrollment
2500
Registered
2009-03-31
Start date
2009-11-02
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Food allergy, food hypersensitivity, eczema, asthma, allergic rhinitis Not Applicable

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

Sponsors

Guy's and St Thomas' NHS Foundation Trust
Lead Sponsor
King's College London (UK)
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
The period prevalence of IgE mediated food allergy to the six intervention foods between one and three years of age in both arms

Secondary

MeasureTime frame
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

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026