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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495583
Recruitment Status : Enrolling by invitation
First Posted : April 12, 2018
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
Action Medical Research
Information provided by (Responsible Party):
King's College London

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.

Condition or disease Intervention/treatment Phase
Food Allergy in Children Obesity, Childhood Food Allergen Sensitisation Other: Early introduction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1235 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Early Introduction of Allergenic Foods Followed by Ad-libitum Consumption, on Food Allergic Sensitisation, Allergy and Measures of Child Health at 8 Years of Age in Exclusively Breastfed Infants
Actual Study Start Date : April 3, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Early introduction
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
Consumption of 2g/week of cow's milk, hen's egg, wheat, peanut, sesame and fish protein from 3 months of age (alongside breastfeeding)

No Intervention: Standard introduction
Infants followed UK DoH standard advice for weaning



Primary Outcome Measures :
  1. Allergic sensitisation [ Time Frame: 3 years ]
    Between group differences in total number of cumulative sensitisations to the six study food allergens at age 8

  2. Food allergy [ Time Frame: 3 years ]
    Between group differences in cumulative food allergy (challenge confirmed) t the six study foods at age 8

  3. Child Health [ Time Frame: 3 years ]
    Between group differences in proportion of children who classified as overweight or obese as determined by their BMI and/or BMI z score


Secondary Outcome Measures :
  1. Other allergic sensitisations [ Time Frame: 3 years ]
    Between group differences in proportion of children with SPT sensitisation to additional food allergens (hazelnut, brazil nut, cashew, almond and walnut) and aero-allergens (timothy grass, birch pollen, house dust mite, cat and dog dander).

  2. Mechanisms of allergy [ Time Frame: 3 years ]
    Between group differences in specific IgE, IgG and IgG4 to peanut, egg, sesame and aeroallergens

  3. Coeliac disease [ Time Frame: 3 years ]
    Between group differences in prevalence of coeliac disease using coeliac antibody test (tTG IgA) screening test

  4. Atopic dermatitis [ Time Frame: 3 years ]
    Between group differences in prevalence of atopic dematitis

  5. Allergic rhinoconjunctivitis [ Time Frame: 3 years ]
    Between group differences in prevalence of seasonal and perennial rhinoconjunctivitis

  6. Asthma [ Time Frame: 3 years ]
    Between group differences in prevalence of asthma

  7. Oral allergy syndrome [ Time Frame: 3 years ]
    Between group differences in prevalence of oral allergy syndrome

  8. Parent reported food allergy [ Time Frame: 3 years ]
    Between group differences in food reaction history (parent-reported immediate onset food allergy)

  9. Sibling allergies [ Time Frame: 3 years ]
    Prevalence of sibling allergies (food allergies, eczema, asthma and rhinitis)

  10. AGE Level in association with food allergies [ Time Frame: 3 years ]
    Between group differences in AGE levels in association with food allergies

  11. Skin fold thickness [ Time Frame: 3 years ]
    Between group differences in skin fold thickness (triceps and subscapular)

  12. Circumference measurements [ Time Frame: 3 years ]
    Between group differences in midarm, waist and head circumference

  13. Anthropometric ratios [ Time Frame: 3 years ]
    Between group differences in; adjusted weight for height; waist; height ratio; height adjusted weight circumference

  14. Fat free mass [ Time Frame: 3 years ]
    Between group differences in fat free mass

  15. Conicity index [ Time Frame: 3 years ]
    Between group differences in conicity index (calculated from waist circumference and height and weight measurements)

  16. Cardiovascular health [ Time Frame: 3 years ]
    Between group differences in the proportion of children with cardiovascular measurements outside the expected range

  17. Vascular stiffness [ Time Frame: 3 years ]
    Between group differences in vascular stiffness

  18. AGE [ Time Frame: 3 years ]
    Between group differences in advanced glycation end products (AGE)

  19. Inflammation [ Time Frame: 3 years ]
    Between group differences in inflammation (measured using IL=6; sensitive CRP; TNF alpha; MCP-1; RANTES chemokine

  20. Metabolic and endocrine [ Time Frame: 3 years ]
    Between group differences in insulin, IGF-1 and leptin

  21. White cell count [ Time Frame: 3 years ]
    Between group differences in total white blood cell count

  22. Macronutrient dietary intake [ Time Frame: 3 years ]
    Between group differences in macronutrient intake

  23. Dietary habits [ Time Frame: 3 years ]
    Between group differences in fussy eating

  24. Physical activity [ Time Frame: 3 years ]
    Influence of physical activity on anthropometry and body composition measurements

  25. Genetic influences [ Time Frame: 3 years ]
    Influence of parental size on: height; weight; waist circumference on participant's size



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495583


Locations
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United Kingdom
Paediatric Allergy
London, United Kingdom
Sponsors and Collaborators
King's College London
Action Medical Research
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Responsible Party: King's College London
ClinicalTrials.gov Identifier: NCT03495583    
Other Study ID Numbers: GN2551
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College London:
Food allergy
Child Health
Oral tolerance induction
Food allergic sensitisation
Obesity
Additional relevant MeSH terms:
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Pediatric Obesity
Hypersensitivity
Food Hypersensitivity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Immune System Diseases
Hypersensitivity, Immediate