Evaluation of the Acquisition of Sustained Unresponsiveness to Cashew Nut Protein Following Oral Allergen-Specific Immunotherapy - Long-Term Follow-Up of Patients From the RCT "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial in the Pediatric Population" (NCT06328504)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Sustained unresponsiveness determined by the outcome of the OFC
研究概览
简要总结
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial in the Pediatric Population", NCT06328504. At the end of the original RCT all participants will undergo an open Oral Food Challenge (OFC) to assess desensitization after 3 months on the maintenance dose of OIT. Patients who have completed the first part of the study will be invited to the current part of the project:
- First arm (initial experimental group) - patients will continue oral immunotherapy (OIT) with cashew nut protein (1200mg) for the next 8 months (+/- 3 weeks).
- Second arm (initial control group - one year on a cashew nut elimination diet) - patients will begin OIT following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months (+/- 3 weeks).
After an additional 8 months (+/- 3 weeks) of OIT, all study participants will undergo a 4-week cessation of treatment, followed by an open Oral Food Challenge (OFC) to assess the development of sustained unresponsiveness (SU).
详细描述
Oral immunotherapy (OIT) is currently recognized as the most effective disease-modifying intervention for IgE-mediated food allergies. The therapeutic objectives of OIT encompass two distinct immunologic outcomes: desensitization and sustained unresponsiveness (SU).
Desensitization refers to a reversible state of increased clinical tolerance to the allergen, dependent on continuous antigen exposure. In contrast, sustained unresponsiveness-considered the optimal endpoint-describes the maintenance of non-reactivity to the allergen following a defined period of OIT discontinuation.
The present study constitutes a long-term follow-up of participants previously enrolled in the randomized controlled trial (RCT) "Efficacy of Cashew Nut Protein Immunotherapy: A Protocol of a Single-Center Randomized Controlled Trial in the Pediatric Population", NCT06328504. Participants who completed the initial treatment phase will be invited to participate in this extended evaluation.
Study Procedures
Following an additional 8 months (±3 weeks) of continued cashew nut protein OIT, eligible participants will undergo a comprehensive in-hospital evaluation, including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cashew nut allergy confirmed prior to the initiation of immunotherapy
- •Completion of the first phase of the study, including achievement of the maintenance dose (1200 mg of cashew nut protein) during immunotherapy
- •Provision of informed consent for participation in the study
- •Adequate cooperation from the patient and/or their legal guardians
排除标准
- •Severe asthma
- •Poorly controlled mild-to-moderate asthma, defined as:
- •FEV1 < 80% (below the 5th percentile),
- •FEV1/FVC ratio < 75% (below the 5th percentile),
- •Hospitalization due to asthma exacerbation within the past 12 months
- •Oral, sublingual, or subcutaneous immunotherapy for other allergens during the first year/season of therapy
- •Eosinophilic gastrointestinal disorders
- •Severe, recurrent episodes of anaphylaxis within the last 6 months
- •Chronic illnesses requiring ongoing treatment, including:
- •Cardiac conditions
- •Metabolic disorders
- •Diabetes mellitus
- •Use of the following medications:
- •Daily oral corticosteroid therapy >1 month within the past 12 months
- •At least two courses of oral corticosteroids (minimum duration of 7 days each) in the past 12 months
- •One course of oral corticosteroids (minimum 7 days) within the past 3 months
- •Biologic therapies
- •Treatment with β-blockers, ACE inhibitors, or calcium channel blockers
- •Pregnancy
- •Lack of informed consent for participation
- •Lack of cooperation from the patient
研究组 & 干预措施
Maintenance dose of cashew nut protein (1200mg) for 8 months
Patients assigned to the experimental group in the first part of the study (RCT) will continue OIT with the maintenance dose of cashew nut protein (1200mg) for the next 8 months.
干预措施: OIT with cashew nut protein (Dietary Supplement)
Immunotherapy initiated after one year of cashew nut avoidance
Patients assigned to the control group in the first part of the study, after one year on a cashew nut elimination diet, will begin immunotherapy following the protocol used in the first part of the study (RCT). Upon completion of this initial phase, they will continue immunotherapy for an additional 8 months.
干预措施: OIT with cashew nut protein (Dietary Supplement)
结局指标
主要结局
Sustained unresponsiveness determined by the outcome of the OFC
时间窗: After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).
Percentage of patients achieving sustained unresponsiveness after 1200 mg cashew nut protein oral immunotherapy, defined as tolerating 4 g of cashew nut powder in OFC after 4 weeks of cashew nut avoidance.
次要结局
- Basophil activation test (BAT)(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Adverse event(11 months on the maintenance dose of OIT (±3 weeks) and a 4 week break (+/- 7 days).)
- Changes in cashew nut protein tolerance during OFC(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- SIgE (specific immunoglobulin E) (kUA/l) levels(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Quality of life - FAQLQ (Food Allergy Quality of Life Questionnaire)(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - wheal diameter in PTS(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Air condensate(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- IgG4 (immunoglobulin IgG4) (mgA/l) levels(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Cut-off Values for Sustained Unresponsiveness Prediction - PTS wheal diameter(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Cut-off Values for Sustained Unresponsiveness Prediction - sIgE(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Determination of Threshold Differences Predictive of Sustained Unresponsiveness - PTS wheal diameter(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Determination of Threshold Differences Predictive of Sustained Unresponsiveness - sIgE(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Evaluation of the Impact of Dose Escalation Duration on OIT Efficacy(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Predictive Markers of Severe Allergic Reactions - sIgE(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)
- Predictive Markers of Severe Allergic Reactions - BAT(After 11 months on the maintenance dose of OIT (±3 weeks) and/or a 4-week break (±7 days).)