Evaluation of the Acquisition of Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Immunotherapy - Long-term Follow-up of Patients From the RCT Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients, NCT06261554.
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
- 2
- 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 and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554. 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 low dose of sesame protein (300mg) for the next 8 months (+/- 3 weeks).
- Second arm (initial control group - one year on a sesame 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 considered the most effective treatment for food allergies. The two primary goals of food immunotherapy are desensitization and sustained unresponsiveness.
Desensitization refers to the induction of temporary tolerance to the allergen, which is maintained only through regular, ongoing exposure. In contrast, the most desirable outcome-sustained unresponsiveness-is defined as the continued absence of allergic reactions to the allergen after discontinuation of immunotherapy for a specified period.
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554.
Patients who completed the initial phase will be invited to participate in the current phase of the project.
After 8 months (+/- 3 weeks) of continued OIT with a low dose of sesame protein, patients will be admitted for hospital-based assessments including skin prick testing, laboratory evaluations, and an open oral food challenge (OFC) to assess the acquisition of desensitization to sesame protein.
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sesame allergy confirmed before starting immunotherapy
- •Completion of the first part of the study - achieving the maintenance dose (300mg sesame protein) during immunotherapy
- •Obtaining informed consent to participate in the study,
- •Patient/carer cooperation.
排除标准
- •Severe asthma,
- •Mild/moderate poorly controlled asthma: FEV1<80% (under
- •percentile), FEV1/FVC<75% (under
- •percentile), hospitalisation for asthma exacerbation in the last 12 months,
- •Oral/sublingual/subcutaneous immunotherapy against other allergens in the first year/season of immunotherapy
- •Eosinophilic gastroenteritis,
- •Severe, recurrent episodes of anaphylaxis within the last 6 months,
- •Chronic diseases requiring ongoing treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
- •Taking medication:
- •oral, daily steroid therapy >1 month in the past 12 months,
- •At least two courses of oral steroid therapy (at least 7 days) within the last 12 months,
- •One oral steroid therapy (min. 7 days) in the last 3 months,
- •biological treatment,
- •therapy with β-blockers, ACE-inhibitors, calcium channel inhibitors,
- •Pregnancy,
- •No consent to participate in the study,
- •Lack of cooperation from the patient.
- •Well-controlled asthma, allergic rhinitis, atopic dermatitis are not considered exclusion criteria.
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 low-dose (300 mg) sesame oral immunotherapy, defined as tolerating 4 g of sesame in OFC after 4 weeks of sesame avoidance.
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 low-dose (300 mg) sesame oral immunotherapy, defined as tolerating 4 g of sesame in OFC after 4 weeks of sesame avoidance.
次要结局
- Changes in sesame protein tolerance during OFC(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).)
- 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).)
- Basophil activation test (BAT)(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).)
- Evaluation of Predictive Factors for the Acquisition 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 Predictive Factors for the Acquisition of Sustained Unresponsiveness - IgG4(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 - the sIgE/tIgE ratio(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 - the sIgE/tIgE ratio(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).)
- Changes in sesame protein tolerance during OFC(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).)
- 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).)
- 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).)
- Basophil activation test (BAT)(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).)
- Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - IgG4(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 - the sIgE/tIgE ratio(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).)
- Evaluation of Predictive Factors for the Acquisition of Sustained Unresponsiveness - 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 - the sIgE/tIgE ratio(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).)