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

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Status: Not yet enrolling

Conditions: Food Allergies

Treatments: Other: Dietary intervention; Procedure: Double-blind placebo-controlled oral challenge test (DBPCFC)

Study type: Observational

Funder types: Other

Identifiers

NCT06997432

PI24/00132 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

32 participants in 2 patient groups

Group 1. Patients on a maximum tolerated dose (MTD) diet.

Description:

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.

Treatment:

Procedure: Double-blind placebo-controlled oral challenge test (DBPCFC)

Group 2. Allergic patients with dietary peach restriction.

Description:

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

Treatment:

Other: Dietary intervention