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Pectin Intervention Study and Long-term Follow-up in Lipid Transfer Proteins Allergic Patients

RecruitingNAAges 18 Years - 60 YearsAllFundación Pública Andaluza para la Investigación …
NCT06558526 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 immunomodulatory effect. Preliminary results by the investigators show that the intervention for 2 months with pectins produces an increase in tolerance to peach, and changes in the microbiota compared to the group of patients treated with placebo. In this project, the investigators aim to study these clinical effects and the involved mechanisms. Moreover, the long-term effect (clinical reactivity to nsLTP and immunomodulatory effect) of the dietary intervention will be prospectively evaluated 6 months after the intervention.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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.
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What it tests

  • Apple pectin (DE 57%)
  • Placebo
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Where

1 site
Hospital Regional Universitario de Málaga
Málaga, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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