Sublingual Immunotherapy for Food Allergy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Validated Questionnaires will be administered to trial participants at 3, 6, 9, 12 months after achieving the maintenance dose of food drops.
研究概览
简要总结
The questions proposed by this study are those of safety and efficacy.
- Concerning safety: "Are sublingual food drops (SLIT) safe enough to be used for stimulation of natural immune suppression in patients with food allergies?"
- Concerning efficacy: "Do the drops suppress food allergy enough for patients to eat previously allergic foods with little or no allergic reaction?"
The aim of this trial is to provide systematic collection of data proving the safety and efficacy of food drops in the correction of food allergy. A patient's range of symptoms, which can include but are not limited to fatigue, nausea, vomiting, diarrhea, abdominal pain, and insomnia can be diagnostic indicators of food allergies.
An approach to answering the above questions can be done by a randomized, controlled, blinded study. The design of our study could be reasonable and powerful because this layout limits bias and accounts for placebo effects:
The patients enrolled in our study will present with food allergy symptoms and diagnostic tests will provide the specific information regarding their food allergies. Once the diagnosis has been made and consent for treatment has been obtained, participants will be randomly assigned to either the group that receives the food allergy intervention with SLIT ( food allergens mixed with 50% glycerin in a vial) or the group that receives the control SLIT (glycerin only). The patients are truly blinded to their treatment because all the SLIT food allergy vials are identical and contain no distinguishing features that could reveal their contents. There is also no difference in taste between a vial containing glycerin and food allergens and a vial containing only glycerin. Therefore, a food allergy SLIT randomized-controlled study can be reasonably achieved.
详细描述
Design:
Randomized-controlled blinded trial to evaluate the safety and efficacy of sublingual immunotherapy for food allergy sufferers. The study will report any adverse events caused by the administration of food allergy drops. Food allergy can manifest itself in many forms including general fatigue, abdominal pain, GERD, nausea, and other symptoms.
End Points:
Comparison between groups 1 and 2 about patient-reported adverse, as well as beneficial, events while on food allergy immunotherapy at 3, 6, 9, 12 months after maintenance dose is achieved (SLIT questionnaire). These comparisons relate to both safety and efficacy issues.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic, reproducible symptoms following meals.
- •Multiple food allergies where dietary avoidance is nearly impossible.
- •Patients age 4 and older.
- •Testing to verify food allergies is positive.
排除标准
- •History of anaphylaxis, angioedema, asthma, or life-endangering reactions to certain food products.
- •Children under the age of
- •Previous attempts to treat food allergy (subcutaneous injections).
- •General medical condition that precludes elective therapy (including pregnancy).
- •Inability to follow food allergy SLIT regimen.
- •Autoimmune Disease.
- •Chronic use of steroids.
结局指标
主要结局
Validated Questionnaires will be administered to trial participants at 3, 6, 9, 12 months after achieving the maintenance dose of food drops.
时间窗: safety and efficacy questionnaires administered at 3, 6, 9, 12 months after achieving the maintenance dose of food drops
次要结局
未报告次要终点
研究者
Robert P. Zitsch III
Department Chair
University of Missouri-Columbia