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

NCT ID: NCT06997432

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Food Allergies

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

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.

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

Intervention Type: PROCEDURE

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.

Group 2. Allergic patients with dietary peach restriction.

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

Dietary intervention

Intervention Type: OTHER

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

Interventions

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

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.

Intervention Type: PROCEDURE

Dietary intervention

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

Intervention Type: OTHER

Eligibility Criteria

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%.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Regional Universitario de Málaga

Málaga, , Spain

Countries

Spain

Central Contacts

Cristobalina Mayorga Mayorga

Role: CONTACT

lina.mayorga@ibima.eu

+34 654464039

Francisca Gómez Pérez

Role: CONTACT

francisca.gomez.p.sspa@juntadeanadalucia.es

699972598

Facility Contacts

Cristobalina Mayorga Mayorga

Role: primary

lina.mayorga@ibima.eu

+34654464039

Other Identifiers

PI24/00132

Identifier Type: OTHER

Identifier Source: secondary_id

PI24/00132

Identifier Type: -

Identifier Source: org_study_id