NCT06997432

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 32 (estimated)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	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.
OTHER	Dietary intervention	Group 2. Patients will take for one year, MTD of fresh peach or peach juice with a frequency of 3 times/week.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: Spain