Trial of food allergy IgE tests for eczema relief

Plain English summary of protocol

Background and study aims
Eczema is common in children and causes dry, itchy and inflamed skin. Symptoms tend to come and go, and there are many reasons why a worsening or “flare” of eczema can happen. Many parents wonder whether a food allergy might be a cause, however, there is currently no good research evidence to support this.
The TIGER study is designed to help doctors and parents understand whether making changes to the diet of children with eczema, based on the results of food allergy tests, improves eczema control or not. The foods we are looking at are cow’s milk, hen’s egg, wheat and soya. Previous research into any link between food allergy and eczema symptoms is limited. This study is needed to help parents and doctors in the future know what is the best thing to do.

Who can participate?
Children aged between 3 months and 2 years, diagnosed with eczema who have not had a previous food allergy test or had an immediate reaction to the study foods (cow’s milk, hen’s egg, wheat and soya)

What does the study involve?
To find out if food allergy testing can improve eczema control, two groups of children (with equal numbers in each group) will be compared. We aim to run the study in up to 123 GP practices in England. Children will attend a study appointment at their GP surgery (or a nearby GP surgery) at the start of the study. During this appointment, children will have a skin assessment, and their growth will be measured. They will also be allocated to one of the two study groups by a process called randomisation. This means that nobody involved (the participants, their GP or the study team) decides or can predict which group each child gets put into. One group of children will receive standard care from their GP plus our ‘Good eczema care’ leaflet. The other group will also receive the leaflet plus they will be given dietary advice to follow for four study foods (cow’s milk, hen’s egg, wheat and soya) based on results from their food allergy tests (skin prick tests). A few children from the dietary advice group may be asked to attend the hospital for a day to make sure that all study foods are safe to eat at home, this is called an Oral Food Challenge. All children in the study will be followed up for 9 months and parents will be asked to complete study questionnaires about their child’s eczema symptoms, treatment use and diet every month during this time. All children will have a follow-up appointment 6 months after their first study appointment, at a time and place of their convenience to re-assess their skin and growth.

What are the possible benefits and risks of participating?
Most people find it rewarding to take part in medical research and appreciate the additional contact with the research team. The findings from the study will help doctors and parents in the future to decide if food allergy testing should be recommended for children with eczema. If the participant is in the dietary advice group, the food allergy tests may provide reassurance or reveal undiagnosed problems. Dietary advice based on the skin prick test results may not make any difference to the participant’s eczema. There is a very small chance that a child may have a reaction to either the skin prick test or the Oral Food Challenge. Usually, any reaction is localised and mild. The risk of a serious (“anaphylaxis”) reaction to skin prick tests is estimated to be less than 1 in a million. In the unlikely event of an emergency, there will be medical help on hand. Study procedures will include questionnaires at each time point. This will require the participant's time, but no other inconvenience or risk is expected. The questionnaires have been reviewed by the study patient and public involvement (PPI) members to ensure they are acceptable to patients.

Where is the study run from?
The University of Bristol with the Bristol Trials Centre (BTC) at the University of Bristol responsible for managing the study (UK)

When is the study starting and how long is it expected to run for?
August 2022 to October 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) Programme (Project reference: NIHR133464)

Who is the main contact?
Prof Matthew Ridd, tiger-study@bristol.ac.uk

Contact information

Prof Matthew Ridd
Principal investigator

Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom

ORCID ID	0000-0002-7954-8823
Phone	+44 (0)117 4552352
Email	m.ridd@bristol.ac.uk

Ms Dominika Corejova
Scientific

Bristol Trials Centre
1-5 Whiteladies Road
Bristol
BS8 1NU
United Kingdom

ORCID ID	0009-0009-6359-2561
Phone	+44 (0)117 455 3039
Email	d.corejova@bristol.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England

Study participating centres

Results and Publications

Study outputs

Additional files

ISRCTN52892540_Protocol_v5.0_23Aug2023.pdf

Protocol file

Editorial Notes

11/08/2025: The date of final enrolment was changed from 31/08/2025 to 22/08/2025.
13/12/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 31/12/2024 to 31/08/2025.
2. The overall study end date was changed from 30/11/2025 to 31/10/2026.
3. The intention to publish date was changed from 30/11/2026 to 30/11/2027.
4. Contact details updated.
11/09/2024: The recruitment end date was changed from 30/09/2024 to 31/12/2024.
18/12/2023: A protocol file has been uploaded.
28/02/2023: Ethics approval details added. The recruitment start date was changed from 01/02/2023 to 01/03/2023.
17/01/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).