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

Официальное название

Analysis of the Clinical Efficacy and Immunomodulatory Effect of Pectin in LTP Allergic Patients Through a Placebo-controlled Intervention Study and Long-term Follow-up

Обзор

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.

Подробное описание

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 intervention study and potential risks. After obtention of written informed consent, screening phase evaluation will be performed (skin prick tests (SPT), obtention of blood and feces samples and double-blind placebo-controlled food challenges (DBPCFC) with peach and peanut). Participants who meet the eligibility requirements will be randomized in a ratio 1:1 to pectin (apple pectin 10 mg + maltodextrin 5 mg; once daily) or placebo (maltodextrin 5 mg; once daily). The dietary intervention will last 6 months and a follow-up visit in month 3 will be performed. After completing the dietary intervention all participants will be clinically assessed (SPT and DBPCFC) and new blood and feces samples will be collected. Finally, patients who receive the active will be clinically evaluated with DBPCFC to peach and peanut after 6 months of completing the dietary intervention. Also, new blood and feces samples will be obtained.

The main objective is to analyze the clinical efficacy of a pectin dietary supplement administered once a day for 6 months as a treatment for nsLTP allergy in a randomized double-blind placebo-controlled multicenter intervention study. In addition, the investigators will study changes in clinical reactivity to nsLTP and the immunomodulatory effect (immunological humoral and cellular, metabolomics and microbiota profiles). Furthermore, long-term effects of the dietary intervention will be analyzed in participants from the active group (pectin) 6 months after completing the intervention.

Вмешательства

• Пищевая добавка Apple pectin (DE 57%)
  Dietary intervention with apple pectin. Participants will orally take the supplement once a day, after dissolving it in 100 ml of water, for 6 months.
• Пищевая добавка Placebo
  Dietary intervention with maltodextrin. Participants will orally take the placebo (maltodextrin) once a day, after dissolving it in 100ml of water, for 6 months.

Первичные конечные точки

• Clinical efficacy of a six-month dietary intervention with pectins in patients with food allergy to peach and peanut due to sensitization to nsLTP. [Срок оценки: 15 months]

Вторичные конечные точки (12)

• Correlation between the induced changes in oral tolerance to peach and/or peanut and the reactivity in skin prick test (SPT). [Срок оценки: 15 months]
• Changes in Pru p 3 and Ara h 9 (nsLTP of peach and peanut, respectively) specific immunoglobulin production (IgE and IgG4) induced by the pectin dietary intervention. [Срок оценки: 15 months]
• Changes in Pru p 3 and Ara h 9-specific basophil activation induced by the pectin dietary intervention [Срок оценки: 15 months]
• Maturational changes in Pru p 3 and Ara h 9-specific dendritics cells induced by the pectin dietary intervention. [Срок оценки: 15 months]
• Pru p 3 and Ara h 9-specific proliferative response of different lymphocytes cell subpopulations after the pectin dietary intervention. [Срок оценки: 15 months]
• Changes on gastrointestinal microbiota induced by the pectin dietary intervention. [Срок оценки: 15 months]
• Changes on feces metabolome induced by the pectin dietary intervention. [Срок оценки: 15 months]
• Changes on serum metabolome induced by the pectin dietary intervention. [Срок оценки: 15 months]
• Pectin dietary intervention long-term clinical efficacy. [Срок оценки: 12 months]
• Pectin dietary intervention long-term effect on the immunological profile. [Срок оценки: 12 months]
• Pectin dietary intervention long-term effect on the gastrointestinal microbiota. [Срок оценки: 12 months]
• Pectin dietary intervention long-term effect on feces metabolome. [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Regional Universitario de Málaga — Málaga

Публикации

• Fernandez-Rivas M, Gonzalez-Mancebo E, Rodriguez-Perez R, Benito C, Sanchez-Monge R, Salcedo G, Alonso MD, Rosado A, Tejedor MA, Vila C, Casas ML. Clinically relevant peach allergy is related to peach lipid transfer protein, Pru p 3, in the Spanish population. J Allergy Clin Immunol. 2003 Oct;112(4):789-95. doi: 10.1016/S0091. PMID 14564363
• Skypala IJ, Asero R, Barber D, Cecchi L, Diaz Perales A, Hoffmann-Sommergruber K, Pastorello EA, Swoboda I, Bartra J, Ebo DG, Faber MA, Fernandez-Rivas M, Gomez F, Konstantinopoulos AP, Luengo O, van Ree R, Scala E, Till SJ; European Academy of Allergy; Clinical Immunology (EAACI) Task Force: Non-specific Lipid Transfer Protein Allergy Across Europe. Non-specific lipid-transfer proteins: Allergen PMID 34025983
• Noval Rivas M, Burton OT, Wise P, Zhang YQ, Hobson SA, Garcia Lloret M, Chehoud C, Kuczynski J, DeSantis T, Warrington J, Hyde ER, Petrosino JF, Gerber GK, Bry L, Oettgen HC, Mazmanian SK, Chatila TA. A microbiota signature associated with experimental food allergy promotes allergic sensitization and anaphylaxis. J Allergy Clin Immunol. 2013 Jan;131(1):201-12. doi: 10.1016/j.jaci.2012.10.026. Epub PMID 23201093
• Bunyavanich S, Berin MC. Food allergy and the microbiome: Current understandings and future directions. J Allergy Clin Immunol. 2019 Dec;144(6):1468-1477. doi: 10.1016/j.jaci.2019.10.019. PMID 31812181
• Zhu Z, Zhu B, Hu C, Liu Y, Wang X, Zhang J, Wang F, Zhu M. Short-chain fatty acids as a target for prevention against food allergy by regulatory T cells. JGH Open. 2019 Jan 8;3(3):190-195. doi: 10.1002/jgh3.12130. eCollection 2019 Jun. PMID 31276034
• Tan J, McKenzie C, Vuillermin PJ, Goverse G, Vinuesa CG, Mebius RE, Macia L, Mackay CR. Dietary Fiber and Bacterial SCFA Enhance Oral Tolerance and Protect against Food Allergy through Diverse Cellular Pathways. Cell Rep. 2016 Jun 21;15(12):2809-24. doi: 10.1016/j.celrep.2016.05.047. PMID 27332875
• Steigerwald H, Blanco-Perez F, Albrecht M, Bender C, Wangorsch A, Endress HU, Bunzel M, Mayorga C, Torres MJ, Scheurer S, Vieths S. Does the Food Ingredient Pectin Provide a Risk for Patients Allergic to Non-Specific Lipid-Transfer Proteins? Foods. 2021 Dec 21;11(1):13. doi: 10.3390/foods11010013. PMID 35010137

Идентификаторы

NCT: NCT06558526 · PI23/00820

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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