ISRCTN ISRCTN10771730
DOI https://doi.org/10.1186/ISRCTN10771730
IRAS number 351201
Secondary identifying numbers CPMS 57927, NIHR206263, RHM CHI1267
Submission date
25/03/2025
Registration date
23/04/2025
Last edited
08/05/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background: Around 1-in-20 UK pre-school children have food allergies. These may be life-long. Allergic reactions sometimes require an adrenaline injection. They may be life-threatening. For the last 30 years, government has recommended that the introduction of solids is delayed until babies reach 6-months of age. Recent large international trials show that introducing common food allergens before 6-months-of-age can prevent food allergies. However, a previous UK trial established that UK parents were unable to introduce common food allergens earlier. Importantly, a recent trial demonstrated that only small tastes of food need to be introduced alongside breast feeding to prevent food allergy. A new approach to support parents/carers to introduce small tastes of food earlier needs to be developed and assessed.

Objectives: To see if we can prevent children developing food allergies by: (1) Working with parents/carers/guardians and healthcare professionals to produce an approach where small tastes of peanut and hen’s egg are introduced from 17-weeks, (2) assessing ease and convenience of the approach, (3) assessing whether the approach can reduce food allergies without affecting children’s health in other ways,(4) is affordable, and (5) plan its use across the National Health Service (NHS).

Methods: (1) Test out the new approach to allergy prevention with a diverse group of parents, carers and healthcare professionals and make any improvements, with 200 parents and carers in four diverse areas in the North-East and South-Coast; then (2) 3000 parents and carers from across UK will have an equal chance of receiving the new advice to introduce tastes from 17-weeks or from around 6-months. We will see whether early introduction of regular, small tastes of hen’s egg and peanuts reduces food allergies at 12-months of age, does not impact on breast feeding and (3) is affordable. Food allergy will be diagnosed using the usual NHS approach (history, skin, blood tests or food challenge).

Patient and public involvement (PPI): The original idea came from participants in previous food allergy prevention studies. They found it difficult to introduce large amounts of food allergens before 6-months. The programme has been developed with a diverse group of parents and carers of children with and without food allergy. For example, they suggested recruiting from vaccination clinics. They felt the proposed design is feasible. Further PPI work with a wider group is ongoing. The PPI panel would be involved in the design, running, interpretation, and circulation of the programme results.

Impact: We will: (1) publish the results in medical journals, (2) present the findings at relevant medical conferences, (3) share the results with research participants and (4) other interested groups. If the new approach is successful, we will (5) work with NHS organisations to introduce it into clinical practice across the UK. If parents/carers start to introduce small tastes of food allergens earlier, the number of babies who develop food allergy could be reduced. This would positively impact families, NHS and society.

Contact information

Mrs Helen Stacey
Public

University of Southampton Faculty of Medicine & University Hospital Southampton NHS Foundation Trust
Southampton
SO16 6YD
United Kingdom

Email h.stacey@soton.ac.uk
Prof Graham Roberts
Scientific, Principal Investigator

Human Development in Health and Clinical & Experimental Science, University of Southampton Faculty of Medicine & University Hospital Southampton NHS Foundation Trust
Southampton
SO16 6YD
United Kingdom

ORCiD logoORCID ID 0000-0003-2252-1248
Email g.c.roberts@soton.ac.uk

Study information

Study designInterventional randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home, Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet.
Scientific titlePreventing food allergy in infants with early introduction of complementary feeding: feasibility and cluster randomised controlled trial
Study objectivesWe hypothesise that a multi-level, online behavioural intervention aimed at supporting parents/carers to introduce regular, small tastes of hen’s egg and peanut at 17-weeks of age, earlier than the current practice of introducing complementary feeding at around 6-months (26-weeks) will reduce the likelihood that infants have IgE-mediated food allergy at 52-weeks of age.
Ethics approval(s)

Approved 29/04/2025, East of England - Cambridge South Research Ethics Committee (Equinox House, City Link, Nottingham, NG2 4LA, United Kingdom; +44 207 104 8096; cambridgesouth.rec@hra.nhs.uk), ref: 25/EE/0067

Health condition(s) or problem(s) studiedPreventing food allergy in infants
InterventionFeasibility: Cluster Controlled Feasibility Trial

We plan to recruit from four sites, allowing us to recruit a socioeconomically and ethnically diverse group. The proposed intervention group includes Newcastle, which covers a large, ethnically mixed inner-city population, and Southampton, which covers a large, less ethnically diverse inner-city and rural population. The proposed control sites are South Tees, which is a smaller, ethnically diverse city population, and the Isle of Wight, which is a small, ethnically less diverse, semi-rural population. All four areas are socioeconomically diverse. Allocating the two large sites to intervention in the feasibility study will allow a different group of general practices to be used for recruitment in the effectiveness trial to prevent contamination if the site is randomized to control.

The intervention site feasibility objectives (recruitment rate, acceptability, safety, age of introduction and frequency of consumption, proportion assessed at 30-weeks of age) mean that participants will need to be followed to 30-months of age. Participants will also be assessed at 52-weeks of age to provide them with the benefit of a food allergy assessment, but the data will not be used as part of the assessment of trial feasibility.

The control site feasibility objectives (recruitment rate, safety, age of introduction and frequency of consumption, proportion assessed at 30- and 52-weeks of age) mean that participants will be followed to 52-weeks of age.

This design has been chosen for efficiency as it allows the control groups to be recruited before the intervention is finalized. The feasibility study outcome will be collected in the same time period, minimizing the length of the program.


Effectiveness Trial (WP3)

A phase 3 cluster randomized controlled trial design. Again, the trial will use a cluster design with each site being a different hospital (although some Trusts may cover more than one hospital). This approach is taken to avoid contamination of the control group given it is a multilevel intervention, i.e., aimed at HCPs as well as parents/carers. An internal pilot would assess recruitment in the first 6-months of recruitment.
Intervention typeOther
Primary outcome measureNew onset IgE-mediated food allergy at 52-weeks of age to peanut and/or hen’s egg on the basis of IgE-mediated symptoms and evidence of specific IgE-sensitisation
Secondary outcome measuresMeasured at 52 weeks' of age using patient records and questionnaire:
1. New onset IgE-mediated food allergy at 52-weeks of age to any food.
2. Age of introduction of peanut, hen’s egg, and cow’s milk, and consumption frequency (information will also be collected about other allergenic foods, including those frequently consumed by specific population groups such as lentils).
3. Resource use and quality of life.
4. Growth (reported weight and length at 12-months of age).
5. Breastfeeding.
6. Adverse events (AEs) elicited by:
- Questionnaires (such as choking, anaphylaxis, allergic reactions).
- Medical notes review (such as respiratory tract infections).
Overall study start date01/04/2025
Completion date31/12/2028

Eligibility

Participant type(s)Carer, Other
Age groupNeonate
Lower age limit0 Months
Upper age limit3 Months
SexBoth
Target number of participantsPlanned Sample Size: 3200; UK Sample Size: 3200
Key inclusion criteria1. Infants aged 0-3 months and their parents/carers
2. Willing and able to give written informed consent
Key exclusion criteria1. Pre-existing food allergy to both peanut and hen's egg.
2. Previous child enrolled in the feasibility or effectiveness trial to prevent an infant experiencing environmental exposure to a food allergen when they are not eating; this does not exclude twins or other multiples being recruited into the study as one time point into the same cluster and therefore allocation.
3. Any major feeding issues unless feeding/gastroenterology clinic say are happy that infant is included.
4. Severe neurodisability that would make early complementary feeding inappropriate.
5. Significant developmental delay (e.g., extremely preterm infants, infants with genetic conditions such as trisomy 21) that would make early complementary feeding inappropriate.
6. Inherited metabolic disorders that necessitate specific feeding regimes.
Date of first enrolment31/05/2025
Date of final enrolment31/12/2027

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

The Newcastle upon Tyne Hospitals NHS Foundation Trust
Freeman Hospital
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Isle of Wight NHS Trust Nmp
St Mary's Hospital
Parkhurst Road
Newport
PO30 5TG
United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
South Tees Hospitals NHS Foundation Trust
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

University Hospital Southampton NHS Foundation Trust
Hospital/treatment centre

Southampton General Hospital, Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Phone +44 2381205213
Email Sharon.davies-dear@uhs.nhs.uk
Website http://www.uhs.nhs.uk/home.aspx
ROR logo "ROR" https://ror.org/0485axj58

Funders

Funder type

Government

NIHR Central Commissioning Facility (CCF)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planOver the 5-year programme, we will work with stakeholders and other interested parties to plan dissemination. As results from the research programme become available, we will feed them back to stakeholders and other interested parties, disseminate key findings to research participants (6-monthly newsletters – email/text, also available via post and on trial website – generated with assistance of PPI group), present at relevant medical conferences, publish findings in a peer reviewed medical journal and disseminate locally and nationally via third sector groups in collaboration with the PPI panel.
IPD sharing planThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Editorial Notes

08/05/2025: The ethics approval was added.
25/03/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).