Oral Immunotherapy for Wheat Allergy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.
研究概览
简要总结
This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.
详细描述
Food allergy affects 6-8 percent of children in the United States. Wheat is one of the eight most common foods inducing allergic reactions in the US. Current treatment for food allergy is complete avoidance of the food and to carry antihistamines and self-injectable epinephrine if an accidental reaction occurs. However, accidental exposure to allergens in processed foods may be difficult to avoid. Currently, several therapeutic strategies are being investigated to prevent and treat food allergies. Since immunotherapy injections for food allergy are associated with a high rate of allergic reactions, alternate approaches to treatment are needed. Oral (by mouth) immunotherapy (OIT) is one approach that has been tried in some studies in the treatment of food allergies. The intent of the study is to examine the clinical effects and safety of wheat OIT. This study will last 2 years. All eligible subjects will receive a wheat oral food challenge (OFC). Those who react to 1923mg or less of vital wheat gluten will be randomized to Wheat OIT or a placebo. All eligible and enrolled subjects will have a 1-year and 2-year OFC. Placebo subjects will crossover to Wheat OIT at the 1-year time point. At selected visits, blood and urine collection, physical examination, prick skin tests, and atopic dermatitis and asthma evaluations will occur.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 4 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4-30 years either sex, any race, any ethnicity
- •Positive Prick Skin Test to wheat greater than 3mm compared to control and/or a wheat specific IgE >= 0.35 kUA/L
- •Positive baseline challenge to wheat (<= 1923 mg of vital wheat gluten)
- •Written informed consent from subject and/or parent/guardian
- •Written assent from all subjects as appropriate
- •All females of child bearing age must be using appropriate birth control
排除标准
- •History of anaphylaxis to wheat resulting in hypotension, neurological compromise or mechanical ventilation
- •Known allergy to corn
- •Known celiac disease
- •Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
- •Active eosinophilic gastrointestinal disease in the past two years
- •Participation in any interventional study for the treatment of food allergy in the past 6 months
- •Subject is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). Subjects tolerating maintenance allergen immunotherapy can be enrolled.
- •Severe asthma, uncontrolled mild or moderate asthma. More information on this criterion can be found in the protocol.
- •A burst of oral, IM or IV steroids of more than 2 days for an indication other than asthma in the past 1 month
- •Inability to discontinue antihistamines for initial day escalation, skin testing or OFC
- •Use of omalizumab or other non-traditional forms of allergen immunotherapy or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year
- •Use of beta-blockers (oral), angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARB) or calcium channel blockers
- •Use of investigational drug within 90 days or plan to use investigational drug during the study period
- •Pregnancy or lactation
研究组 & 干预措施
Wheat OIT
Active treatment participants receive Vital Wheat Gluten, and have up to four oral food challenges as directed by the protocol.
干预措施: Wheat OIT (Drug)
Placebo
Placebo for Vital Wheat Gluten followed by crossover to open-label active therapy (Vital Wheat Gluten), and up to three oral food challenges as directed by the protocol.
干预措施: Wheat OIT (Drug)
结局指标
主要结局
The Percentage of Desensitized Participants as Measured by the Ability to Consume at Least 4443 mg of Wheat Protein During a 7443 mg Wheat Protein Oral Food Challenge (OFC) Performed 1 Year After Initiating Treatment.
时间窗: 1 Year
Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.
次要结局
- Number of Subjects Who Successfully Consume a Wheat Protein Oral Food Challenge(8 to 10 weeks after passing the 2 Year OFC)
- Number of Subjects Who Achieve the Targeted Maintenance Dose of Wheat OIT(44 Weeks)
- Number of Subjects That Achieve Desensitization in the Placebo Cross Over Group(2 Years)
- Incidence of All Serious Adverse Events During the Study.(1 year and 2 Years)
研究者
Hugh A Sampson, MD
Dean for Translational Biomedical Sciences, Director, Jaffe Food Allergy Institute
Icahn School of Medicine at Mount Sinai