Patterns of Adult Food Allergy (PAFA-Stage 3)

Patterns and prevalence of adult food allergy in a UK population - PAFA-Stage 3

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN55184289

Enrollment

190

Registered

2022-10-18

Start date

2022-09-19

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgE-mediated food allergy in adults Not Applicable

Interventions

Individuals with a probable food allergy will be identified from the PAFA-Stage 2 study, and the Manchester Asthma and Allergy Study (MAAS) and Isle of Wight 1989 birth cohorts and invited for clinica

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 09/12/2022: 1. Have probable (or suggestive symptoms for cohort members) IgE-mediated food allergy or those in whom further clinical evaluation is deemed necessary to exclude a food allergy and either be respondents to PAFA-Stage 2 who agreed to be recontacted about PAFA Stage 3 or be members of the MAAS and Isle of Wight 1989 cohorts 2. Be capable of giving informed consent Previous participant inclusion criteria: All must be either respondents to the PAFA-Stage 2 community survey aged 18-70 years and consent to be invited to take part in PAFA-Stage 3, or members of either the MAAS or Isle of Wight 1989 birth cohorts with a probable food allergy

Exclusion criteria

Exclusion criteria: Adults who have dementia, Alzheimer’s disease, or are receiving palliative care

Design outcomes

Primary

Measure	Time frame
1. Confirmed food allergy (IgE-mediated): 1.1. Clinician confirmed: defined as self-reported symptoms associated with consumption of a particular food which are typical of an IgE-mediated food allergy, with symptom onset within 2 hours measured by a detailed food allergy questionnaire and review of medical history and evidence of sensitization to the same food measured by a skin prick testing and/or venepuncture (a blood sample withdrawal) and serological analysis 1.2. Oral food challenge confirmed: measured by a double-blind placebo-controlled food challenge 2. Inconclusive: confirmed by a clinician as the reported (and measured by a questionnaire and review of medical history) signs/symptoms not clearly attributable to an IgE-mediated food allergy and oral food challenge not performed. 3. Tolerant: 3.1. Measured by a double-blind placebo-controlled food challenge that is rated negative 3.2. Clinician confirmed (measured by a detailed questionnaire and review of medical history) tolerance Measured at up to five visits depending upon the clinical case and at times based on patient availability. The final outcome will be decided by the expert panel which will take account of information collected across visits 1-5 for PAFA Stage 3.	—

Measure

Time frame

1. Confirmed food allergy (IgE-mediated): 1.1. Clinician confirmed: defined as self-reported symptoms associated with consumption of a particular food which are typical of an IgE-mediated food allergy, with symptom onset within 2 hours measured by a detailed food allergy questionnaire and review of medical history and evidence of sensitization to the same food measured by a skin prick testing and/or venepuncture (a blood sample withdrawal) and serological analysis 1.2. Oral food challenge confirmed: measured by a double-blind placebo-controlled food challenge 2. Inconclusive: confirmed by a clinician as the reported (and measured by a questionnaire and review of medical history) signs/symptoms not clearly attributable to an IgE-mediated food allergy and oral food challenge not performed. 3. Tolerant: 3.1. Measured by a double-blind placebo-controlled food challenge that is rated negative 3.2. Clinician confirmed (measured by a detailed questionnaire and review of medical history) tolerance Measured at up to five visits depending upon the clinical case and at times based on patient availability. The final outcome will be decided by the expert panel which will take account of information collected across visits 1-5 for PAFA Stage 3.

—

Secondary

Measure	Time frame
Possible non-IgE-mediated adverse reactions to food, defined as self-reported adverse reactions to food that are characteristic of non-IgE-mediated food allergy and develop after 2 hours of the food consumption (measured by a detailed questionnaire) and a negative skin prick test and or no presence of specific IgEs as (measured by venepuncture and serological analysis). Measured at up to five visits depending upon the clinical case and at times based on patient availability. The final outcome will be decided by the expert panel which will take account of information collected across visits 1-5 for PAFA Stage 3.	—

Measure

Time frame

Possible non-IgE-mediated adverse reactions to food, defined as self-reported adverse reactions to food that are characteristic of non-IgE-mediated food allergy and develop after 2 hours of the food consumption (measured by a detailed questionnaire) and a negative skin prick test and or no presence of specific IgEs as (measured by venepuncture and serological analysis). Measured at up to five visits depending upon the clinical case and at times based on patient availability. The final outcome will be decided by the expert panel which will take account of information collected across visits 1-5 for PAFA Stage 3.

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026