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| Name | Class |
|---|---|
| Institute of Biomedical Research in Málaga (IBIMA) | UNKNOWN |
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Omalizumab has demonstrated efficacy, increasing the tolerance threshold in patients with multiple food allergies, as well as reducing the risk of severe reactions when used as monotherapy. This favors improving the reactivity profile of patients with food allergy. In our setting, plant allergy caused by sensitization to panallergens such as lipid transfer proteins (LTPs) and profilins entails important limitations for the consumption of a healthy diet due to the extensive dietary restrictions.
The main objective of this project is to analyze the efficacy of treatment with omalizumab administered every 2-4/weeks, used in monotherapy in patients with plant allergy due to sensitization to profilin and LTPs and those patients in whom sublingual immunotherapy with Pru p 3 (peach LTP), has not been effective, by performing a before-after study we will evaluate the changes in clinical reactivity to LTP (peach) and profilin (melon) and the changes immunological effect after omalizumab intervention. In addition, we will evaluate the changes in reactivity to at least one food other than peach and melon in the different sensitization profiles.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omalizumab Injection | Drug | Treatment with omalizumab in monotherapy for 16 weeks in patients allergic to vegetables due to sensitization to lipid transfer proteins (LTPs) and profilin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in tolerated dose of peach or melon during physician-supervised oral food challenge (PPO) in patients with vegetable allergy due to sensitization to lipid transfer proteins (LTPs) or profilin | Clinical efficacy will be assessed by measuring the change in the amount (grams) of peach (in LTP-allergic patients) or melon (in profilin-allergic patients) tolerated during a physician-supervised oral food challenge (PPO) after 16 weeks of omalizumab monotherapy. The oral food challenge will be conducted according to standardized EAACI protocols, and the maximum tolerated dose without objective symptoms will be recorded. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To analyze the changes induced in the immunological profile after the intervention: -Humoral: IgE and IgG4 levels to peach LTP (Pru p 3) and palm tree profilin (Pho d 2) by immunoassays. | 16 weeks | |
| To analyze the changes induced in the immunological profile after the intervention: 2.2-Cellular: activation of peach LTP basophils (Pru p 3) and palm profilin (Pho d 2) by flow cytometry. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with allergy to plant foods due to sensitisation to LTP and profilin
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MarÃa José Torres Jaén, MD, PhD | Contact | 952131615 | mjtorresj@uma.es | |
| Francisca Gómez Pérez | Contact | 699972598 | francisca.gomez.p.sspa@juntadeanadalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| MarÃa José Torres Jaén, MD, PhD | Hospital Regional de Malaga | Principal Investigator |
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| ID | Term |
|---|---|
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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Peripheral blood samples will be collected at baseline (T0), 2 months (T2), and 4-5 months (T4) after initiation of omalizumab treatment. A total of 60 mL of peripheral blood will be obtained per timepoint: 10 mL in serum separator tubes for humoral studies, 10 mL in lithium heparin tubes for basophil activation test (BAT), and the remaining volume processed using Ficoll gradient for isolation and cryopreservation of peripheral blood mononuclear cells (PBMCs) in liquid nitrogen for future cellular and genomic analyses. Immunological assays include measurement of total and specific IgE and IgG4 to Pru p 3 and Pho d 2 (via ImmunoCAP), and basophil activation test (BAT) analyzed by flow cytometry. Samples may be used for further omics or genetic studies.
| 16 weeks |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |