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NCT Number: NCT06997432

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

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.

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Key information

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Regional Universitario de Málaga

Málaga, 29010, Spain

Location contact

Cristobalina Mayorga Mayorga

CONTACT

[email protected]

+34654464039

Cristobalina Mayorga Mayorga

PRINCIPAL_INVESTIGATOR

Francisca Gómez Pérez

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

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.

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.

Primary outcomes

  1. Changes in the distribution of immune cell populations after MTD exposure

    Time frame: 1 year

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Cristobalina Mayorga Mayorga

CONTACT

[email protected]

+34 654464039

Francisca Gómez Pérez

CONTACT

[email protected]

699972598

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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