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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Elaine Gauson
+44 (0)161 3065 795
elaine.gauson@manchester.ac.uk


Study Location:

University Hospital Southampton NHS Foundation Trust
Mailpoint 18 Southampton General Hospital Tremona Road
Southampton
SO16 6YD


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Patterns of Adult Food Allergy (PAFA-Stage 1)

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Adult food allergy


This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.




Background and study aims
Many people in the UK suffer from food allergies and intolerances, which cause problems for them when choosing what to eat, buying food, and eating outside the home. Although this is well recognised in children, it affects many adults too. Researchers would like to find out how many adults in the UK have food allergies and intolerances. In this study a community survey in Greater Manchester, Isle of Wight, and Southampton will allow adults aged 18-70 to report their experiences of symptoms related to eating food, excluding food poisoning. The study locations are representative of populations within the UK and will allow us to collect food allergy information on a diverse range of ethnic groups and backgrounds.

Who can participate?
People aged between 18 and 70 years old registered with GP practice in Greater Manchester, Southampton, or Isle of Wight, and participants in one of the Isle of Wight FAIR food allergy cohorts

What does the study involve?
Volunteers are invited to take part in the questionnaire through their local GP surgeries and can respond online, by post, or telephone. Additionally, a group of participants from a previous food allergy study (Food Allergy and Intolerance Research [FAIR]) will be invited to complete a modified version of the community survey. All questionnaire responses are transferred to a secure online research platform (REDCap). Participants are identifiable only by their unique identification number (UID) linked to their questionnaire response. Participants are invited to indicate their interest in receiving further information to take part in allergy assessments.

What are the possible benefits and risks of participating?
The benefits to participants is that they will be invited to participate in Stage 2 of the study and will be further evaluated as to any food or associated allergy to e.g. pollen that they might have. Also, the data gathered in this study will contribute to our understanding of food allergy which will help update current public health policies regarding food allergy including prevention and treatment so may benefit patients in the future. There is a small potential risk of causing upset if for example an invitation letter is sent to a deceased person. Every effort will be made by the GP practice to use current up to date GP record information to contact potential participants to avoid this situation.

Where is the study run from?
Universities of Manchester, Southampton, and Amsterdam University Medical Centre with Manchester Foundation Trust, University Hospital Southampton and Isle of Wight NHS Trusts (UK)

When is the study starting and how long is it expected to run for?
November 2018 to October 2028

Who is funding the study?
Food Standards Agency

Individuals affected by food allergy experience considerable illness, with all aspects of their lives being affected by a restricted diet and the risk of future reactions. Furthermore, individuals with IgE-mediated (immune response) allergies can experience severe, reactions which can be fatal. IgE- mediated food allergy is responsible for 65% of hospitalisations due to adverse reactions to food. Like many immune-mediated conditions, allergic disease, including food allergy, results from complex interactions between genetic and environmental risk factors which result in differences in incidence between rural and urban communities. More evidence is required about the prevalence of adult food allergy and intolerance such as the patterns and risk factors linked with its development in order to develop effective policies seeking to manage, prevent and treat such conditions. This information is also valuable for making decisions about which foods to include on priority lists for allergen labelling, such as Annex II of the Food information for consumers regulation (FIR) and to support approvals of novel foods and processes (including foods from Genetically Modified Organisms).


Multicentre study which uses two complementary epidemiological approaches:1. A cross-sectional study (community survey)2. Follow-up of the Food Allergy and Intolerance Research (FAIR) food allergy cohorts (population cohorts)

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

30 Aug 2019

31 Mar 2020

Observational

Intervention Type : Other
Intervention Description : Community Survey (Questionnaire 1A)Adults aged 18-70 years old living in Greater Manchester, Isle of Wight and Southampton will be invited by their local GP to take part in a short questionnaire (Questionnaire 1A- 2 pages) about food allergy. Overall, an estimated 35,000 invites will be sent. The GP surgeries involved in the study will send a letter (Letter 1A) to potential participants informing them about the study along with the Participant Information Sheet (PIS 1A) (explains the study, the role of the participant, how data will be used, and important contact information of the study team), and a paper copy of the questionnaire with a paid reply envelope. This will be posted to potential participants using contact information held in GP records through an outsourced mailing company (e.g. Docmail which is routinely used by GP practices). At the bottom of the questionnaire a statement translated into languages relevant to the study population (e.g. Urdu and Hindi) will state that the study documents are also available in other languages upon request.The questionnaire can be completed by participants in one of three ways; online using a unique link associated with a unique identification number (UID) provided to the participant, by completing the paper questionnaire and posting it back to their local study centre (Manchester Foundation Trust, University Hospital Southampton NHS Foundation Trust, and Isle of Wight NHS Trust), or by telephone (on NHS-based telephone number provided in the postal letter) with a member of the research team quoting their UID. The study researcher will enter the questionnaire responses given over the telephone by the participant into the e-Questionnaire directly. Postal responses will also be transcribed by a study researcher and entered into the e-Questionnaire using a computer based in the relevant NHS Trust. In addition, if potential participants have a mobile phone registered with their GP, they will receive a text message reminder (from their GP surgery via an EMIS approved text message service e.g. MJOG), with the link to the online questionnaire, a few days after receiving the written information through the post. A digital copy of the PIS will also be made available to participants who respond to the questionnaire on digital devices.

Cohort Survey (Questionnaire 1B)In addition to the community survey, previous participants of the FAIR cohort will be re-contacted and invited to take part in the survey (subject to permission to obtain contact details being sought from CAG as part of this application). The original UID for FAIR cohort participants will be reused. Documents will be sent to each FAIR participant including an explanatory cover letter (Letter 1B) from the FAIR study team, the participant information sheet 1B (PIS 1B) and a food allergy questionnaire (Questionnaire 1B) with a reply paid envelope. The questionnaire will be the same as the community survey with the addition of a few questions about asthma, eczema and allergic rhinitis. Participants can respond to Questionnaire 1B using the same methods as the community survey (1a).

Participants of Questionnaire 1A and B will be eligible to enter a prize draw for £250 of vouchers (e.g. Amazon, or love2shop). All responses to the questionnaires (1A and B) will be gathered together on a secure online research platform called REDCap, allowing for data sharing and analysis of pseudonymised data (personal information such as name and address will not be linked to questionnaire responses). It is estimated that there will be 10,000 responses from the community survey (1A) and 2,300 responses from the cohort survey (1B). Only those within the study team with permission to view and analyse the data will be granted access using a secure login and password. Participants will be asked at the end of the questionnaire "Can we contact you with information about the second stage of the study?". Participants that indicate an interest may be invited to take part in follow-up allergy assessment visit (blood and skin prick tests) as cases and controls based on their responses to the questionnaire.


You can take part if:


1. Community survey 1.1. Must be aged between 18 and 70 years old1.2. Registered with GP practice in Greater Manchester, Southampton, or Isle of Wight

2. Population cohorts2.1. Participant in one of the Isle of Wight FAIR food allergy cohorts




You may not be able to take part if:

Does not meet inclusion criteria


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University Hospital Southampton NHS Foundation Trust
    Mailpoint 18 Southampton General Hospital Tremona Road
    Southampton
    SO16 6YD
  • Manchester University NHS Foundation Trust (Wythenshawe)
    Southmoor Rd Wythenshawe
    Manchester
    M23 9LT
  • Isle of Wight NHS Trust (St Mary's Hospital)
    Pankhurst Road Newport
    Isle of Wight
    PO30 5TG
  • University of Manchester
    Manchester Institute of Biotechnology John Garside Building 1.021 Oxford Road
    Manchester
    M13 9PL
  • University of Southampton
    Paediatric Allergy and Respiratory Medicine Tremona Road
    Southampton
    SO16 6YD


The study is sponsored by Manchester University NHS Foundation Trust and funded by Food Standards Agency.



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for Trial ID: ISRCTN72819770

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