Clinical Trials

Improved Diagnostics in Food Allergy Study

Study Purpose

The investigators will conduct low-dose intranasal allergen challenges on children and young people with an indeterminate diagnosis of food allergy to cow's milk or peanut. Blood samples will also be taken, for conventional blood allergy diagnostics (allergy-specific Immunoglobulin E) and mast cell activation test (MAT). The data will be used to determine the diagnostic accuracy of two complementary, novel approaches to diagnose food allergy, in a representative clinical cohort.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	2 Years - 18 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- IgE-sensitisation to peanut, (hen's) egg or cow's milk, with indeterminate clinical (allergy) status, defined as IgE-sensitisation below 95% positive predictive value (PPV) for diagnosis for either allergen-specific IgE or SPT, using published cut-offs OR clinician suspicion of tolerance (on basis of clinical history) despite IgE sensitisation >95% PPV cut-offs.

- Written informed consent from parent/guardian, with assent from children aged 6 years and above wherever possible.

Participants aged over 16 years will need to provide their own informed consent.

Exclusion Criteria:

- Acute illness or current unstable asthma, defined as: 1.

Febrile ≥38.0oC in last 72 hours. 2. Acute wheeze in last 72 hours requiring treatment. 3. Recent admission to hospital in preceding 2 weeks for acute asthma.

- Current medication.

1. Asthma reliever medication required in preceding 72 hours. 2. Recent administration of a medicine containing antihistamine within the last 3 days. 3. Current oral steroid for asthma exacerbation or course completed within last 2 weeks. - Unwilling or unable to fulfil study requirements

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06097572
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Imperial College London
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	Ireland, United Kingdom
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Food Allergy

Arms & Interventions

Arms

Experimental: Peanut

Participants with possible allergy to peanut

Experimental: Cow's Milk

Participants with possible allergy to cow's milk

Interventions

Diagnostic Test: - Intranasal food challenge

Subjects will undergo an incremental intranasal challenge to initially 0.9% NaCl saline solution, and then increasing doses of the food protein

Diagnostic Test: - Mast cell activation test

Blood will be processed for mast cell activation as previously described (https://doi.org/10.1016/j.jaci.2018.01.043)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Prof Jonathan Hourihane, Dublin, Ireland

Status

Address

Prof Jonathan Hourihane

Dublin, ,

London, United Kingdom