Endophenotyping for Plant-based Food Allergy Diagnosis, Tolerance Biomarkers, and Mechanisms in Microneedle Immunotherapy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age14-65
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

About this trial

In relation to the prognosis of vegetable FA (VFA), in contrast to other food allergies (FA), which disappear naturally with time, VFA tends to persist into adulthood and to the appearance of new sensitizations to other vegetables. The paradigm of early intervention in patients with risk factors for developing FA has changed in recent years, with evidence that maintaining a controlled diet with foods with potential allergic risk in a population of children at risk has shown efficacy in early intervention. An important aspect would be the selection of the dose of the food to be included in the diet. In this sense, recent studies on the standardization of the double-blind placebo-controlled oral challenge test (DBPCFC) in allergic patients to Lipid Transfer Proteins (LTP) with known amounts of Pru p 3 (peach LTP), have observed that the maximum tolerated dose (MTD) was equivalent to 40 grams of peach with skin. Based on these results and those obtained in the pediatric population, this study aims to evaluate whether the maintenance in the diet of a DMT evaluated in a DBPCFC could influence tolerance (desensitization) to the food at both clinical and immunological levels.

Eligibility criteria

Qualifiers

Women and men

14-65 years-old

Peach allergy due to sensitization to LTP confirmed by skin tests and/or IgEe positive to Pru p 3.

Sign informed consent.

Disqualifiers

Pregnant of lactating women.

Patients with immunological diseases, mental illness or severe atopic dermatitis.

Patients treated with immunomodulators and/or β-blockers

Patients with forced expiratory volume (FEV1)<70%.

Trial design

Treatments tested in this trial

  • Double-blind placebo-controlled oral challenge test (DBPCFC)
  • Dietary intervention

Treatment groups

32 Participants
are divided into 2 treatment groups