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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

Tracking Information
First Submitted Date  ICMJE April 4, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date April 12, 2018
Actual Study Start Date  ICMJE April 3, 2018
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Allergic sensitisation [ Time Frame: 3 years ]
    Between group differences in total number of cumulative sensitisations to the six study food allergens at age 8
  • Food allergy [ Time Frame: 3 years ]
    Between group differences in cumulative food allergy (challenge confirmed) t the six study foods at age 8
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • 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).
  • Mechanisms of allergy [ Time Frame: 3 years ]
    Between group differences in specific IgE, IgG and IgG4 to peanut, egg, sesame and aeroallergens
  • Coeliac disease [ Time Frame: 3 years ]
    Between group differences in prevalence of coeliac disease using coeliac antibody test (tTG IgA) screening test
  • Atopic dermatitis [ Time Frame: 3 years ]
    Between group differences in prevalence of atopic dematitis
  • Allergic rhinoconjunctivitis [ Time Frame: 3 years ]
    Between group differences in prevalence of seasonal and perennial rhinoconjunctivitis
  • Asthma [ Time Frame: 3 years ]
    Between group differences in prevalence of asthma
  • Oral allergy syndrome [ Time Frame: 3 years ]
    Between group differences in prevalence of oral allergy syndrome
  • Parent reported food allergy [ Time Frame: 3 years ]
    Between group differences in food reaction history (parent-reported immediate onset food allergy)
  • Sibling allergies [ Time Frame: 3 years ]
    Prevalence of sibling allergies (food allergies, eczema, asthma and rhinitis)
  • AGE Level in association with food allergies [ Time Frame: 3 years ]
    Between group differences in AGE levels in association with food allergies
  • Skin fold thickness [ Time Frame: 3 years ]
    Between group differences in skin fold thickness (triceps and subscapular)
  • Circumference measurements [ Time Frame: 3 years ]
    Between group differences in midarm, waist and head circumference
  • Anthropometric ratios [ Time Frame: 3 years ]
    Between group differences in; adjusted weight for height; waist; height ratio; height adjusted weight circumference
  • Fat free mass [ Time Frame: 3 years ]
    Between group differences in fat free mass
  • Conicity index [ Time Frame: 3 years ]
    Between group differences in conicity index (calculated from waist circumference and height and weight measurements)
  • Cardiovascular health [ Time Frame: 3 years ]
    Between group differences in the proportion of children with cardiovascular measurements outside the expected range
  • Vascular stiffness [ Time Frame: 3 years ]
    Between group differences in vascular stiffness
  • AGE [ Time Frame: 3 years ]
    Between group differences in advanced glycation end products (AGE)
  • Inflammation [ Time Frame: 3 years ]
    Between group differences in inflammation (measured using IL=6; sensitive CRP; TNF alpha; MCP-1; RANTES chemokine
  • Metabolic and endocrine [ Time Frame: 3 years ]
    Between group differences in insulin, IGF-1 and leptin
  • White cell count [ Time Frame: 3 years ]
    Between group differences in total white blood cell count
  • Macronutrient dietary intake [ Time Frame: 3 years ]
    Between group differences in macronutrient intake
  • Dietary habits [ Time Frame: 3 years ]
    Between group differences in fussy eating
  • Physical activity [ Time Frame: 3 years ]
    Influence of physical activity on anthropometry and body composition measurements
  • Genetic influences [ Time Frame: 3 years ]
    Influence of parental size on: height; weight; waist circumference on participant's size
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The EAT-On Study: Sensitisation, Allergy and Child Health
Official Title  ICMJE 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
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.
Detailed Description

Sensitisation/Allergy:

Food allergy (FA) is common, increasing in prevalence and represents a public health concern in many countries. FA increasingly affects geographic regions where rates of FA were previously low.(1-5) Data from the Enquiring About Tolerance (EAT) study, which enrolled 1303 exclusively breastfed three month old babies from the general population, showed that 8% of children had proven immediate-onset FA at three years of age. This equates to almost 1 in 10 children. (1) The early-introduction of specific food allergen(s) to infant diets is a successful strategy for the prevention of FA. Introduction of peanut to the infant diet before 11 months of age, protected against the development of peanut allergy in a high-risk, atopic population.(6) This effect persisted despite cessation of peanut consumption for 12 months.(7) In the EAT Study, children from the general population were randomised either to consume six commonly allergenic foods (cow's milk, egg, peanut, wheat, fish and sesame) from four months of age (early introduction group (EIG)), or to follow Department of Health (DoH) advice to exclusively breastfeed until about 6 months of age (standard introduction group (SIG)). The per-protocol analysis revealed a reduction in any FA of 7.3% versus 2.4% (p=0.01), for peanut allergy of 2.5% versus 0% (p=0.003) and for egg allergy 5.5% versus 1.4% (p=0.009) in the SIG and EIG respectively. (8) In the EAT study, between 1 and 3 years an intention-to-treat analysis (ITT) of sensitisation to individual foods showed a significant cumulative treatment effect of 35% (p=0.0095) in the EIG (unpublished data). Furthermore, in the per-protocol analyses (PP), we showed a statistically significant reduction of 41.6% (p=0.01) in skin prick test (SPT) sensitivity to any food at 1 year, and again at 3 years with a 67.3% relative reduction (RR) (p=0.002) in the EIG. These findings were particularly significant for individual food; at 3 years there was a relative reduction in skin-prick sensitivity to all individual foods and particularly for peanut (RR 67.1% p=0.007).

FA is a dynamic condition with egg and milk allergy typically developing in infancy and being outgrown and peanut and sesame allergy usually developing between the ages of 3-6 and persisting into adulthood. Whilst early introduction of commonly allergenic foods is effective in preventing food allergy in early childhood and within the confines of a randomised controlled trial (RCT), the longevity of this novel approach has not been tested and little is known about whether these effects are sustained after 'real world' ad libitum consumption. The EAT-On Study aims to investigate this by following-up children who were previously enrolled in the EAT Study when they are 8 years of age and investigating the natural history of food allergy, and how the intervention that was applied when children were 4-6 months of age influences food allergic sensitisation and clinical food allergy when they are 8 years of age.

Child Health:

Whilst the UK Department of Health recommends exclusive breastfeeding (EBF) until around six months of age, surveys suggest this is achieved by only 1% of mothers(9). Given the lack of EBF till 6 months of age, the majority of infants will require additional nutrition provided from formula and/or solid weaning foods. Indeed, 75% of infants have been introduced to solid food by 5 months of age (9). The nutritional consequences of different weaning regimens may have important consequences on obesity outcomes, but rigorous trials in this area are difficult to undertake, not least because of the necessary ethical concerns that pertain to the comparison of breast-feeding with alternate or complementary feeding strategies. The EAT cohort presents a unique opportunity to study this question further as the diet consumed by children who participated in the EIG of the EAT study is much higher in protein than breastmilk alone. Good quality studies have found that consumption of high protein formula milk in early infancy increases the risk of overweight in later childhood compared with breastfeeding, but the effect of high protein solid food consumption alongside breastfeeding in early infancy has not been studied. The majority of infants have solid food introduced before 6 months of age, and updated guidance advocates the introduction of a high protein food (peanut) from 'around 6 months of age' (UK(10) and Australia(11)), or at 4 months of age (USA(12)) to prevent a new onset of peanut allergy. It is therefore timely to explore how early diet, particularly with respect to high protein weaning diet, influences childhood obesity. This will lead to the development of clearer guidance in respect to early weaning diet which extends to other high protein foods, while taking in to account the risk of childhood obesity.

The nature of the EAT cohort means that between 4 and 6 months of age children were randomised either to a lower protein diet (SIG) or to a higher protein diet (EIG): breastmilk contains approximately 6% energy from protein whilst the EIG were asked to consume a diet containing at least 15% energy from protein, more than double that of the SIG. This cohort therefore offers a unique opportunity to explore the effect of differing energy consumption from dietary protein on overweight/obesity and markers of cardiovascular health in later childhood.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Food Allergy in Children
  • Obesity, Childhood
  • Food Allergen Sensitisation
Intervention  ICMJE 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)
Study Arms  ICMJE
  • 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.
    Intervention: Other: Early introduction
  • No Intervention: Standard introduction
    Infants followed UK DoH standard advice for weaning
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
1235
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03495583
Other Study ID Numbers  ICMJE GN2551
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party King's College London
Study Sponsor  ICMJE King's College London
Collaborators  ICMJE Action Medical Research
Investigators  ICMJE Not Provided
PRS Account King's College London
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP