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

This trial does not accept healthy volunteers

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 population

Women and men aged 14-65 years with peach allergy due to sensitization to LTP confirmed by skin tests and/or IgEe positive to Pru p 3.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Procedure/Surgery

    Group 1. To evaluate MTD, DBPCFC will be done with peach with skin and/or peach juice as described. The patient will remain under observation for at least 2 hours.

  • Dietary intervention

    Other intervention

    Group 2. Patients will take for one year, MTD of fresh peach or peach juice with a frequency of 3 times/week.

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Group 1. Patients on a maximum tolerated dose (MTD) diet.1 intervention
Group B: Group 2. Allergic patients with dietary peach restriction.1 intervention

Trial outcomes

Primary outcomes

1

Changes in the distribution of immune cell populations after MTD exposure

Study of the clinical and immunological implications of maintaining in the diet the maximum tolerated dose identified in a controlled food exposure test according to the sensitization profile to LTPs (Real-time pilot study).

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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