Swedish Study of Immunotherapy for Milk Allergy in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Number of participants that achieve tolerance to milk
研究概览
简要总结
This trial is a two-armed open randomized controlled trial in children aged 5-15 years with challenge proven Immunoglobulin E (IgE)-associated milk allergy.The purpose is to determine if oral immunotherapy with milk can induce tolerance to milk. The active intervention is intake of increasing amounts of fresh milk for six months followed by three years of maintenance treatment with milk. The control group continues their elimination (milk free) diet. The trial will recruit patients at ten pediatric departments in Sweden, coordinated by Umeå University. The primary outcome is milk tolerance (defined as a negative double-blind placebo-controlled milk challenge) at trial completion 3.5 years after start of treatment. Secondary outcomes include allergic symptoms during treatment documented as certain allergic manifestations, changes in immunological and microbial biomarkers, quality of life and nutritional status.
详细描述
The underlying hypothesis is that exposure to milk in a controlled way can be delivered safely and induce tolerance to milk.The aim of this trial is to evaluate a specific protocol for oral milk intake to achieve sustainable tolerance.
Before randomization all patients are tested for milk allergy using a double-blind placebo-controlled milk challenge and baseline laboratory analyses (specific IgE). Patients with confirmed, challenge-proven milk allergy are randomized to oral immunotherapy (active group) or milk-free diet (control group).The active group will receive a stepwise increase in oral milk intake. The increased dose will be given in hospital outpatient clinics by experienced study staff following a standard protocol. All other doses are given att home where the patients have adrenaline ready to use. When the patient has reached a daily intake of 100 ml of milk without serious allergic reactions they will be maintained on this dosis for three years. At this stage (after finished dose escalation or after six months for the control group) the patients will be tested for the second set of laboratory analyses.
During maintenance, the patients in the active group are encouraged not to avoid milk protein and instead eat milk-containing food when it is offered. Patients in the control group receive standard care with exclusion of milk from their diet for the whole trial duration.
After three years of maintenance therapy for the active group, both groups avoid milk for one week and then undergo a double-blind placebo-controlled milk challenge and the third set of samples for immunological comparison.
The immunological markers are Immunoglobulins (E, G4, A), microbiota and basophilic activation. All patients are also evaluated for quality of life and nutritional status.
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
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Immunoglobulin E (IgE) milk >0.1 kU/L
- •Allergic reaction within 2 hours after intake of milk protein
- •Age 5-15 years
排除标准
- •Uncontrolled asthma, >12 % increase in Forced Expiratory Volume in 1 second (FEV1) after inhaled bronchodilatator and Asthma Control Test (ACT)<20
- •No allergic reaction at a controlled milk challenge
- •Severe immune deficiency
- •Autoimmune disease
- •Chronic urticaria
- •Eosinophil esophagitis
- •Pregnancy and breastfeeding
- •Ongoing immunotherapy to one or more allergens
结局指标
主要结局
Number of participants that achieve tolerance to milk
时间窗: 3.5 years after start of treatment
Tolerance is defined as absence of IgE-mediated allergic symptoms connected to a double-blind placebo-controlled milk challenge
次要结局
- Changes in level of IgG4 milk in blood(Baseline, 6 months, 3.5 years)
- Changes in overall microbial composition in stools(Baseline, 6 months, 3.5 years)
- Changes in level of basophil activation (CD sens) in blood(At baseline, after 6 months, after 3.5 years)
- Changes in level of IgA in saliva(Baseline, 6 months, 3.5 years)
- Changes in Quality Of Life: FAQLQ-PF(At baseline, after 3.5 years)
- Changes in nutritional status(At baseline, after 3.5 years)
- Frequency of treatment-demanding adverse effects(3.5 years)
- Changes in level of IgE milk in blood(Baseline, 6 months, 3.5 years)
- Changes in overall microbial composition in saliva(Baseline, 6 months, 3.5 years)
研究者
Christina West
Associate professor/Principal investigator
Umeå University