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

NCT06997432 | Not Yet Recruiting

• 1 other identifier: PI24/00132
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Vegetable food allergy; Allergy desensitization; Lipid Transfer Proteins

Outcome Measures

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).

  1 year

Study Arms (2)

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.

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

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.

Other: Dietary intervention

Interventions

Double-blind placebo-controlled oral challenge test (DBPCFC) 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 1. Patients on a maximum tolerated dose (MTD) diet.

Dietary intervention OTHER

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

Group 2. Allergic patients with dietary peach restriction.

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Women and men
• years-old
• Peach allergy due to sensitization to LTP confirmed by skin tests and/or IgEe positive to Pru p 3.
• Sign informed consent.

You may not qualify if:

• 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%.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

Location

MeSH Terms

Conditions

Food Hypersensitivity

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Central Study Contacts

Cristobalina Mayorga Mayorga

CONTACT

+34 654464039; lina.mayorga@ibima.eu

Francisca Gómez Pérez

CONTACT

699972598; francisca.gomez.p.sspa@juntadeanadalucia.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 30, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)