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
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