Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-28 @ 10:55 AM
Study NCT ID:
NCT06997432
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-30
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endophenotyping for Plant-based Food Allergy Diagnosis, Tolerance Biomarkers, and Mechanisms in Microneedle Immunotherapy
Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PI24/00132 | OTHER | Carlos III Health Institute | View |