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临床试验/JPRN-jRCTs031180391
JPRN-jRCTs031180391已完成2 期

Efficacy and safety of TGF-rich food in oral Immunotherapy for milk allergy: a randomized, double-blind, placebo-controlled clinical trial - Efficacy and safety of TGF-rich food in oral Immunotherapy

Fujisawa Takao0 个研究点目标入组 16 人开始时间: 2019年3月20日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
16

研究概览

简要总结

To test possible efficacy of an immunomodulatory TGF-containing milk product in combination with oral immunotherapy for milk allergy, a randomized placebo-controlled clinical trial was performed. A total of 14 patients were enrolled in the study. All the patients in TGF group (100%) achieved initial desensitization status, whereas 63% in placebo group achieved desensitization. Adverse events caused by OIT tended to be fewer in TGF group than placebo group. The preliminary result may warrant further study.

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 3age old 至 <= 15age old(—)
性别
All

入选标准

  • 1.IgE-mediated milk allergy
  • 2.Immediate allergic symptoms are induced in oral milk challenge at cumulative dose of milk more than 3 ml and 25 ml or less
  • 3. Written informed consent by a guardian and informed ascent by a participant(child)

排除标准

  • Severe anaphylactic symptoms at oral milk challenge

研究者

发起方
Fujisawa Takao

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