Efficacy and Safety of Low-dose Sesame Oral Immunotherapy in Pediatric Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Tolerance of sesame
研究概览
简要总结
It is a randomized, single-center, controlled trial to evaluate the effectiveness of oral immunotherapy with low-dose sesame protein compared with standard treatment (elimination diet) in patients with sesame allergy.
详细描述
Allergic reactions to sesame can be severe and life-threatening, making it challenging to avoid hidden sources of the allergen.
This pilot study is a randomized controlled trial evaluating the efficacy and safety of oral immunotherapy (OIT) with a low-dose sesame protein in pediatric patients with sesame allergy. The study aims to compare participants undergoing OIT with a maintenance dose of 300mg sesame protein against a control group in a 2:1 randomized allocation. The control group will be recommended a standard treatment, which is a restrictive elimination diet and the use of emergency treatment, including adrenaline, in case of accidental exposure to sesame.
39 participants aged 3-17 with confirmed IgE-mediated sesame allergy will be enrolled into the study. Interventions will be administered once daily for up to 18 months, and the control group will stay under observation for one year.
Primary outcomes include the proportion of participants tolerating a single dose of 4000mg sesame protein during the final oral food challenge. Secondary outcomes assess adverse events, changes in immunological parameters, and the maximum tolerated doses of sesame protein in each group.
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
- 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
- •Age between 3 and 17 years,
- •IgE-mediated sesame allergy confirmed with positive skin prick tests with sesame allergens (diameter of the wheal greater than 3mm) and/or specific IgE level greater than 0.35-kilo units of Allergen per liter (kUA/l),
- •Allergic reaction to sesame protein during oral food challenge (OFC),
- •Signed Informed Consent by parent/legal guardian and patient aged >16 years old,
- •Patient's and caregivers' cooperation with the researcher.
排除标准
- •No confirmed sesame allergy,
- •Negative OFC with sesame protein (maximum dose 4000mg),
- •Severe asthma, uncontrolled mild/moderate asthma: forced expiratory volume at one second (FEV1)<80% (under
- •percentile), FEV1/forced vital capacity (FVC)<75% (under
- •percentile), hospitalization due to asthma exacerbation within last 12 months,
- •Current oral/sublingual/subcutaneous immunotherapy with other allergens in the first year of immunotherapy,
- •Eosinophilic gastroenteritis,
- •A history of severe recurrent anaphylaxis episodes,
- •Chronic diseases requiring continuous treatment, including heart disease, epilepsy, metabolic diseases, diabetes,
- •Medication:
- •oral, daily steroid therapy longer than 1 month within the last 12 months,
- •at least two courses of oral steroid therapy (at least 7 days) within the last 12 months,
- •oral steroid therapy longer than 7 days within the last 3 months,
- •any biological treatment,
- •therapy with β-blockers, angiotensin-converting enzyme (ACE) inhibitors, calcium channel inhibitors,
- •Pregnancy,
- •No consent to participate in the study,
- •Lack of patient or caregiver cooperation.
结局指标
主要结局
Tolerance of sesame
时间窗: Up to 18 months after starting oral immunotherapy
The proportion of participants who tolerate the single dose of 4000mg sesame protein at the conclusion of the study.
次要结局
- Adverse event(Up to 18 months after starting oral immunotherapy)
- Skin prick test (SPT)(Up to 18 months after starting oral immunotherapy)
- Basophil activation test(Up to 18 months after starting oral immunotherapy)
- Laboratory data(Up to 18 months after starting oral immunotherapy)
- Desensitization dose(Up to 18 months after starting oral immunotherapy)