Endophenotyping for Plant-based Food Allergy Diagnosis, Tolerance Biomarkers, and Mechanisms in Microneedle Immunotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Double-blind placebo-controlled oral challenge test (DBPCFC), Dietary intervention.
- Who it may be relevant to
- Registry conditions: Food Allergies. Basic parameters: 14 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Changes in the distribution of immune cell populations after MTD exposure [Time frame: 1 year]
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%.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Regional Universitario de Málaga — Málaga
Identifiers
NCT: NCT06997432 · PI24/00132 · PI24/00132