Status:
RECRUITING
Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients
Lead Sponsor:
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Conditions:
Food Allergy
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Pectins are dietary fibers that have shown a health effect on patients with food allergy, as they are capable of modifying the composition of gastrointestinal microbiota, and producing an immunomodula...
Detailed Description
Patients of 3 different Allergy Units with clinical history of allergic reactions with peach and with/without reactions with peanut due to sensitization to nsLTP will be informed about the interventio...
Eligibility Criteria
Inclusion
- Adults with a clear clinical history of food allergy after eating peach (oral allergy syndrome and/or systemic symptoms) and with or without clinical history of food allergy with peanut.
- Sensitization to Pru p 3 by positive skin prick test (SPT wheal area \>7 mm2) and specific IgE (sIgE \>0.35 kUA/L)
- Positive DBPCFC with peach juice.
- If clinical history of food allergy with peanut, sensitization must be confirmed by positive SPT to peanut and sIgE \>0.35 kUA/L to Ara h 9 and clinical reactivity through a positive DBPCFC with peanut.
- Signed informed consent.
Exclusion
- Food allergy to corn.
- Food allergy to peanut due to sensitization to storage proteins.
- Previous/active treatment with sublingual immunotherapy to Pru p 3.
- Pregnancy/lactation.
- Active infections.
- Inflammatory, autoimmune, and/or oncological diseases.
- Severe immunodeficiency.
- Metabolic syndrome.
- Increased liver parameters and/or any liver disease.
- Alcohol disorder.
- Mental illness.
- Mast cell activation syndrome.
- Severe atopic dermatitis.
- FEV1 \< 70%
- Treatment with immunomodulators in the last five years.
- Vitamin supplements, probiotics, prebiotics, antibiotics, metformin, statins, proton pump inhibitors, or corticosteroids in the last three months.
- Any clinical condition contraindicating performance of DBPCFC.
Key Trial Info
Start Date :
January 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06558526
Start Date
January 13 2025
End Date
November 30 2026
Last Update
June 15 2025
Active Locations (1)
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1
Hospital Regional Universitario de Málaga
Málaga, Málaga, Spain, 29009