The EAT-On Study: Sensitisation, Allergy and Child Health

NCT03495583 | Unknown DMC

• 1 other identifier: GN2551
• Study Type: interventional
• Target: 1,235
• Locations: 1 country
• Sites: 1

Brief Summary

The EAT Study showed a reduction in both sensitisation (to all foods) and clinical food allergy (to peanut and egg) among children who consumed allergenic food early compared with those who followed standard government feeding advice to exclusively consume breast milk for the first 6 months of life. The EAT-On Study aims to establish whether the effects seen at 3 years in the EAT study represent a delay in FA onset or sustained tolerance. EAT-On will also investigate the natural history (emergence and resolution) of FA in childhood; thus shaping dietary and management plans for allergic patients. Findings will inform future research and weaning recommendations for preventing FA.

Conditions

Food Allergy in Children; Obesity, Childhood; Food Allergen Sensitisation

Keywords

Food allergy; Child Health; Oral tolerance induction; Food allergic sensitisation; Obesity

Outcome Measures

Primary Outcomes (3)

• Allergic sensitisation

  Between group differences in total number of cumulative sensitisations to the six study food allergens at age 8

  3 years

• Food allergy

  Between group differences in cumulative food allergy (challenge confirmed) t the six study foods at age 8

  3 years

• Child Health

  Between group differences in proportion of children who classified as overweight or obese as determined by their BMI and/or BMI z score

  3 years

Secondary Outcomes (25)

• Other allergic sensitisations

  3 years

• Mechanisms of allergy

  3 years

• Coeliac disease

  3 years

• Atopic dermatitis

  3 years

• Allergic rhinoconjunctivitis

  3 years

Study Arms (2)

Early introduction

EXPERIMENTAL

Six commonly allergenic foods introduced (in a randomly assigned order) into the diets of exclusively breastfed infants from about 3 months of age.

Other: Early introduction

Standard introduction

NO INTERVENTION

Infants followed UK DoH standard advice for weaning

Interventions

Early introduction OTHER

Consumption of 2g/week of cow's milk, hen's egg, wheat, peanut, sesame and fish protein from 3 months of age (alongside breastfeeding)

Early introduction

Eligibility Criteria

• Age: 7 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Previous participation in the EAT study
• Age 8 years +/- 12 months

You may not qualify if:

• None

Sponsors & Collaborators

• King's College London: lead
• Action Medical Research: collaborator

Study Sites (1)

Paediatric Allergy

London, United Kingdom

Location

MeSH Terms

Conditions

Pediatric Obesity; Food Hypersensitivity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial in which breastfed infants were randomised (equal groups) either to introduce 6 allergenic foods (cow's milk, egg, wheat, peanut, sesame, fish) from 3 months of age or to continue exclusive breastfeeding until about 6 months of age.

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 12, 2018
• Study Start: April 3, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 12, 2018

Record last verified: 2018-03

Locations

GB (1)