Effect of food sample shelf life on prick-to-prick test reproducibility

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional study compares prick-to-prick skin test results obtained at the same visit using fresh native foods versus the same foods stored for varying periods (frozen or dried) in adults with known IgE-mediated food allergies. Each participant serves as their own control and may have several foods tested in a single roughly 30-minute session to avoid intra-individual variability. The main outcomes are concordance and reproducibility of wheal responses between fresh and stored samples, with 30 minutes of post-test observation by allergology nurses. Participants meet inclusion criteria including age ≥18 and prior diagnosis of grade 2–3 food allergy with evidence of sensitization; those with recent severe reactions or interfering medications are excluded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Aged 18 and over.
2. Having a diagnosis of food allergy(ies) due to one or more of the food allergen studied, previously made by an allergologist, of grade 2 to 3 according to the Ring and Messmer classification.
3. Having given consent to participate in the study.

The diagnosis is made by the allergologist of the department due to the presence of a compatible clinical history implicating the tested allergen, the presence of evidence of sensitization to the allergen (positive prick-test and/or positive specific IgE assays), or even a positive oral allergen reintroduction test.

Exclusion Criteria:

1. Anaphylactic reaction dating less than 6 weeks
2. Hospitalization for asthma in the past 3 months
3. History of grade 4 anaphylactic reaction according to the Ring and Messmer classification.
4. Systemic antihistamine treatment in the 7 days preceding the test
5. Systemic beta-blocker treatment on the day of the test.
6. Protected person (under guardianship or curatorship)
7. Person under judicial supervision
8. Persons deprived of liberty
9. Person not affiliated with a social security insurance
10. Pregnant or breastfeeding women

Where it's running

• Centre Hospitalier Universitaire d'Orléans
  Orléans, France Recruiting

Study contacts

• Study coordinator: Minaxi Dr PATEL, PhD
• Email: minaxi.patel@chu-orleans.fr
• Phone: 238613223

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.