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临床试验/NCT04552522
NCT04552522已完成不适用

Immunological Response After Shrimp Oral Immunotherapy Treatment

Mahidol University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年8月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Change in Eliciting Dose of Shrimp During Oral Food Challenge

研究概览

简要总结

Oral immunotherapy is effective in desensitized food allergy. Shrimp allergy is increasing in Thailand. So the purpose of our study is to determine level of specific immunoglobulin E antibodies to shrimp, Immunoglobulin G4 and immunoblot analysis in shrimp allergy patients after shrimp oral immunotherapy.

详细描述

All subject in this study were sensitized to shrimp. All patient was clinically evaluated, with focus on shrimp allergy by medical history, medical examination and gold standard oral food challenge test. Compare oral immunotherapy to shrimp and shrimp avoidance. Blood sample was taken for baseline determination of immunoglobulin E antibodies to shrimp. The primary outcome was the specific immunoglobulin E antibodies to shrimp,Immunoglobulin G4 and immunoblot analysis in case that oral immunotherapy.

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
12 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 12 - 40 years old
  • History of Immunoglobulin E-mediated shrimp allergy > 3 episode/year or disturb quality of life
  • Positive oral food challenge test for shrimp

排除标准

  • History of shrimp anaphylaxis (include cardiovascular or neurological symptoms)
  • Shellfish dependent exercise induced anaphylaxis
  • History of cardiovascular disease, uncontrolled asthma, severe atopic dermatitis
  • History of Beta-blocker, Angiotensin-converting enzyme inhibitor, Angiotensin receptor blocker, Calcium channel blocker

研究组 & 干预措施

Shrimp allergy with Intend to eat shrimp

Experimental

Case shrimp Immunoglobulin E mediated allergy and intend to eat shrimp and start oral immunotherapy for shrimp

干预措施: shrimp allergy with intend to eat shrimp (Other)

Shrimp allergy with avoid shrimp

No Intervention

Case shrimp allergy with avoid shrimp

结局指标

主要结局

Change in Eliciting Dose of Shrimp During Oral Food Challenge

时间窗: Baseline and 12 months

Change in the eliciting dose (ED) of shrimp protein during oral food challenge from baseline to 12 months in participants with shrimp allergy undergoing shrimp oral immunotherapy compared with avoidance.

specific Immunoglobulin E, Immunoglobulin G4, immunoblot analysis from Desensitized to shrimp allergen

时间窗: 1 year

To follow-up the level of specific Immunoglobulin E, Immunoglobulin G4, immunoblot analysis from Desensitized to shrimp allergen

次要结局

  • Adverse Event From Shrimp Oral Immunotherapy(1 year)
  • Adverse event from Shrimp oral immunotherapy(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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