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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Clinical efficacy of a six-month dietary intervention with pectins in patients with food allergy to peach and peanut due to sensitization to nsLTP.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Treatment will be blinded to the participants and research team.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Food allergy to corn.
- •Food allergy to peanut due to sensitization to storage proteins.
- •Previous/active treatment with sublingual immunotherapy to Pru p
- •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.
结局指标
主要结局
Clinical efficacy of a six-month dietary intervention with pectins in patients with food allergy to peach and peanut due to sensitization to nsLTP.
时间窗: 15 months
Clinical efficacy will be defined as an increase in oral tolerance to peach and/or peanut determined through the DBPCFCs performed pre- and post- dietary intervention, compared to the Placebo.
次要结局
- 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.(15 months)
- Changes on serum metabolome induced by the pectin dietary intervention.(15 months)
- Changes in Pru p 3 and Ara h 9-specific basophil activation induced by the pectin dietary intervention(15 months)
- Changes on gastrointestinal microbiota induced by the pectin dietary intervention.(15 months)
- Pectin dietary intervention long-term clinical efficacy.(12 months)
- Pectin dietary intervention long-term effect on the gastrointestinal microbiota.(12 months)
- Pectin dietary intervention long-term effect on serum metabolome.(12 months)
- Pectin dietary intervention long-term effect on feces metabolome.(12 months)
- Maturational changes in Pru p 3 and Ara h 9-specific dendritics cells induced by the pectin dietary intervention.(15 months)
- Changes on feces metabolome induced by the pectin dietary intervention.(15 months)
- Correlation between the induced changes in oral tolerance to peach and/or peanut and the reactivity in skin prick test (SPT).(15 months)
- Pru p 3 and Ara h 9-specific proliferative response of different lymphocytes cell subpopulations after the pectin dietary intervention.(15 months)
- Pectin dietary intervention long-term effect on the immunological profile.(12 months)