Food AllergiesNCT06997432
Endophenotyping for Plant-based Food Allergy Diagnosis, Tolerance Biomarkers, and Mechanisms in Microneedle Immunotherapy
An observational study of Food Allergies, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Food Allergies
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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%.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Regional Universitario de Málaga
Málaga, 29010
Cristobalina Mayorga Mayorga, +34654464039, lina.mayorga@ibima.eu
Cristobalina Mayorga Mayorga
About this study
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
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
- Being tested
- Double-blind placebo-controlled oral challenge test (DBPCFC), Dietary intervention
- Keywords
- Vegetable food allergy, Allergy desensitization, Lipid Transfer Proteins
- Medical subject headings
- Food Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double-blind placebo-controlled oral challenge test (DBPCFC)Procedure or surgery
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 interventionOther
Group 2. Patients will take for one year, MTD of fresh peach or peach juice with a frequency of 3 times/week.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food AllergiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997432
- Sponsor's protocol ID
- PI24/00132
- Other IDs
- PI24/00132
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06997432
- Acronym / sponsor ID
- PI24/00132
- Conditions
- Food Allergies
- Keywords
- Vegetable food allergy, Allergy desensitization, Lipid Transfer Proteins
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1. Patients on a maximum tolerated dose (MTD) diet. | – | Procedure: Double-blind placebo-controlled oral challenge test (DBPCFC)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 2. Allergic patients with dietary peach restriction. | – | Other: Dietary interventionPatients will take for one year, MTD of fresh peach or peach juice with a frequency of 3 times/week. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group 1. Patients on a maximum tolerated dose (MTD) diet. |
| Dietary interventionGroup 2. Patients will take for one year, MTD of fresh peach or peach juice with a frequency of 3 times/week. | Other | Group 2. Allergic patients with dietary peach restriction. |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Food Allergies, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cristobalina Mayorga Mayorga (+34 654464039, lina.mayorga@ibima.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the distribution of immune cell populations after MTD exposure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.