Trial of food allergy IgE tests for eczema relief
| ISRCTN | ISRCTN52892540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52892540 |
| IRAS number | 318832 |
| Secondary identifying numbers | CPMS 54714, IRAS 318832 |
- Submission date
- 15/12/2022
- Registration date
- 17/01/2023
- Last edited
- 13/12/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Skin and Connective Tissue Diseases
Plain English Summary
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
Principal Investigator
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-7954-8823 |
|---|---|
| Phone | +44 (0)117 4552352 |
| m.ridd@bristol.ac.uk |
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 |
| d.corejova@bristol.ac.uk |
Study information
| Study design | Pragmatic multicentre parallel-group individually randomized controlled superiority trial with internal pilot and nested economic and process evaluations |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Trial of food allergy IGe tests for Eczema Relief (TIGER): individually randomised controlled trial (with internal pilot and nested economic and process evaluations) comparing the effect of skin prick test-guided dietary advice with standard care on eczema control in children |
| Study acronym | TIGER |
| Study hypothesis | Does dietary advice based on routine food allergy tests improve disease control compared with standard care in children with eczema? |
| Ethics approval(s) | Approved 24/02/2023, North West - Greater Manchester Central Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048328, (0)2071048131; gmcentral.rec@hra.nhs.uk); ref: 22/NW/0387 |
| Condition | Management of eczema in children aged between 3 months and 2 years |
| Intervention | Participants are randomised on a 1:1 basis using an online randomisation system. Group 1 - Intervention. Participants are given skin prick test-guided dietary advice for four study foods (cow's milk, hen's egg, wheat and soya), plus a 'Good eczema care' leaflet. (For safety, some participants may also have an oral food challenge at their local allergy centre, to ensure that advice to include foods at home does not risk a sudden, IgE-mediated, potentially life-threatening reaction). Group 2 - Comparator/standard care. Participants are given a 'Good eczema care' leaflet. |
| Intervention type | Behavioural |
| Primary outcome measure | Eczema control measured using the caregiver-reported version of RECap for AtoPic eczema (RECAP) questionnaire collected four-weekly for 24 weeks |
| Secondary outcome measures | 1. Eczema control measured using the caregiver-reported version of RECap for AtoPic eczema (RECAP) questionnaire at 28 weeks, 32 weeks and 36 weeks 2. Eczema symptoms measured using a Patient-Oriented Eczema Measure (POEM) questionnaire four-weekly for 36 weeks 3. Itch severity measured using Numerical Rating Scale Peak Pruritis during the last 24 hours (PP-NRS) questionnaire four-weekly for 36 weeks 4. Eczema severity measured using Global eczema severity score four-weekly for 36 weeks 5. Eczema signs measured using Eczema Area Severity Index (EASI) at baseline and 24 weeks 6. Child quality of life (disease-specific) measured using an Infant Dermatitis Quality of Life (IDQOL) questionnaire at baseline, 24 weeks and 36 weeks 7. Child quality of life (generic) measured using Child Health Utility 9D scale (CHU-9D) questionnaire at baseline, 12 weeks, 24 weeks and 36 weeks 8. Growth of children measured using calculation of head circumference, weight-for-age, stature-for-age, and weight-for-stature at baseline and 24 weeks 9. Parent quality of life measured using the EuroQol-5 Dimension (EQ-5D-5L) and EQ-VAS questionnaires at baseline, 12 weeks, 24 weeks and 36 weeks 10. Parent quality of life measured using the Care Related Quality of Life (CarerQol) questionnaire at baseline, 24 weeks and 36 weeks 11. Parental anxiety measured using a Generalised Anxiety Disorder 7 (GAD-7) questionnaire at baseline, 24 weeks and 36 weeks 12. Breastfeeding status of the mother measured using questions from the Infant Feeding Survey four-weekly for 36 weeks 13. Healthcare resource use measured using the Resource Use Measure (RUM, including ModRUM and bespoke questions) at 12 weeks, 24 weeks and 36 weeks 14. Ingestion of study foods measured using a bespoke questionnaire four-weekly for 36 weeks 15. Use of topical treatments for eczema measured using a bespoke questionnaire four-weekly for 36 weeks 16. Eczema/food allergy genes measured in an optional DNA saliva sample measured using LGC Genomics using KASP genotyping technology at baseline or 24 weeks 17. Adverse events (including the development of food allergy) measured using medical notes captured throughout the full duration of participation |
| Overall study start date | 01/08/2022 |
| Overall study end date | 31/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Months |
| Upper age limit | 2 Years |
| Sex | Both |
| Target number of participants | 493 |
| Participant inclusion criteria | 1. Aged between 3 months and less than 2 years 2. Have eczema diagnosed by an appropriately qualified healthcare professional 3. Have mild, moderate or severe eczema (Patient Orientated Eczema Measure (POEM) score >2 within the previous 28 days) 4. Be accompanied by an adult who is able to give consent |
| Participant exclusion criteria | 1. Confirmed or probable* immediate (IgE-type) food allergy to the study foods 2. Previous skin prick test (SPT) or IgE blood test for the study foods 3. Another child in the household already taking part in the trial * Parents who report symptoms, which in the opinion of the allergy panel/their GP, are suspicious of an immediate-type reaction. |
| Recruitment start date | 01/03/2023 |
| Recruitment end date | 31/08/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Lewins Mead
Bristol
BS1 2NT
United Kingdom
Tollbar Way
Hedge End
Southampton
SO30 2UN
United Kingdom
Citylabs
Nelson Street
Manchester
M13 9NQ
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Marlborough Street
Bristol
BS1 3NU
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Sponsor information
University/education
Research and Enterprise Division
Augustine's Courtyard
Orchard Lane
Bristol
BS1 5DS
England
United Kingdom
| Phone | +44 (0)117 4553343 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | http://www.bristol.ac.uk/red/research-governance/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/11/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Working with public contributors, we will develop and maintain a user-friendly website to publicise progress, stories and blogs to generate interest in the study. Through these mechanisms, we will reach many of the clinical, academic and lay audiences who have an interest in the subject area. This will generate some pathways to impact at an early stage in the study. In addition to our final monograph, we will publish the trial protocol and results in peer-reviewed journals and present them at local, national and international meetings. Publications resulting from the quantitative and qualitative components of the study will cross-reference each other and include a universal trial reference number so that the studies can be located more easily. We will of course feed the results back to participating GP surgeries and participants. We will disseminate the study findings to the wider NHS audience, via the Academic Health Science Network (AHSN) (Network of Networks) and partner organisations such as Allergy UK, producing a range of tailored outputs that are appropriate for the end user (decision makers, patients, researchers and clinicians), for example, executive (“actionable”) summaries. In addition, we will produce a short video presentation/animation for sharing on websites such as YouTube, continuing medical education websites and through local community organisations. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored on the University Research Data Storage Facility (RDSF) and will be available upon request from the Chief Investigator, Prof Matthew Ridd (m.ridd@bristol.ac.uk, or appointed nominee). The type of data that will be shared is anonymous research data, which may include qualitative audio recordings and/or associated data such as anonymised transcripts. Consent will be obtained from all participants for anonymous data to be shared with other researchers. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No | ||
| Protocol file | version 5.0 | 23/08/2023 | 18/12/2023 | No | No |
Additional files
Editorial Notes
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).
