Oral Immunotherapy for Young Children With Peanut Allergy - Small Children OIT (SmaChO)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Sustained unresponsiveness to 750 mg peanut protein
研究概览
简要总结
Open label study with peanut oral immunotherapy (OIT). Peanut allergic children aged 1-3 years of age will be randomized 2:1 to:
- Peanut OIT with slow up-dosing (40-60 weeks) up to a maintenance dose of 285 mg daily oral peanut protein or
- Control group with peanut allergic children who do not undergo OIT.
- In addition, a group of healthy children without allergic diseases will be included in the study.
The primary outcome is tolerance to at least 750 mg peanut protein at a challenge after 3 years and sustained unresponsiveness (i.e. tolerance) to 750 mg peanut protein after 3 years of OIT followed by 4-6 weeks of avoidance.
Efficacy and safety will be compared between group 1 and 2. Group 3 is a control group for analyses of immunological markers.
详细描述
Problem: Today there is no clinically available treatment for peanut allergy. Oral Immunotherapy (OIT) studies have shown promising results, particularly in younger children (<4 years).
Intervention: Peanut OIT in children aged 1-3 years with peanut allergy (clinical symptoms at peanut challenge and IgE >0.1 kU /l to peanut and/or Ara h 2).
Comparison: Three groups are compared. Peanut allergic children are randomized 2:1 to group 1 (active OIT) or group 2 (control). Group 3 consists of age-matched non-allergic children:
Group 1; Children with peanut allergy receiving peanut OIT, slow up-dosing, 40-60 weeks, until the maintenance dose 285 mg peanut protein. Three years' treatment. (n=50 patients)
Group 2; Age-matched children with peanut allergy who do not undergo OIT peanut (peanut avoidance group). Peanut challenges are performed one and three years after inclusion. (n=25 patients)
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, Care Provider, Investigator)
盲法说明
Blinded randomisation process after a positive baseline peanut challenge (for both participants, care provider and investigator) by opaque envelops.
After the child is randomised to treatment or avoidance, everyone (particpant, care provider and investigator) know if the child is in the treatment or avoidance group.
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children 1 - 3 years old at inclusion
- •Positive baseline challenge at a maximum of the 250 mg peanut protein-dose with at least one objective symptom, or positive peanut challenge performed in the clinic in a similar way within 1 year from study start.
- •IgE-ab to peanut and/or Ara h 2 ≥0.1 kUA/l, analyzed within 12 months from start of study
- •Written consent for participation in the study from both Guardians
排除标准
- •Other serious illness
- •Previously life-threatening anaphylaxis (intensive care), regardless of the triggering agent
- •A history of eosinophilic esophagitis (EoE), other eosinophilic gastrointestinal disease, severe chronic gastroesophageal reflux disease (GERD), symptoms of dysphagia, unclear recurrent GI disorders
- •Participation in another intervention study, if included in intervention Group
- •Severe uncontrolled asthma
- •Ongoing medication with biological drugs or oral steroids
结局指标
主要结局
Sustained unresponsiveness to 750 mg peanut protein
时间窗: 3 years and 4-6 weeks
Sustained unresponsiveness to 750 mg peanut protein (cumulative dose) at a peanut challenge after 3 years of OIT and 4-6 weeks of peanut avoidance. Measured at a peanut challenge
次要结局
- Immunological biomarkers(3 years)
- Tolerance to peanut protein at a challenge after 1 year(1 year)
- Adverse events during OIT treatment(3 years)
- Quality of Life Before, during and after OIT peanut(3 years)
- Intestinal microbiome(3 years)
- Tolerance to peanut protein at a challenge after 3 years(3 years)
研究者
Carina Uhl
PhD student
Karolinska Institutet