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临床试验/ACTRN12608000594325
ACTRN12608000594325已完成2 期

Study of the effectiveness of Probiotics and Peanut Oral Immunotherapy (P-POIT) in inducing desensitisation or tolerance in children with peanut allergy

Royal Children's Hospital0 个研究点目标入组 90 人开始时间: 2008年11月25日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
1 Years 至 10 Years(—)
性别
All

入选标准

  • Children are eligible for the study if they:
  • 1) Are aged between 1 year and 10 years of age
  • 2) Are above 10kg
  • 3) There is a confirmed diagnosis of peanut allergy as defined by:
  • -a positive food challenge to peanut in the past 2 years AND a positive skin prick test (SPT) or Capsulated Hydrophobic Carrier Polymer- Radioallergosorbent Test (CAP-RAST) to peanut
  • -a positive food challenge or history of reaction to peanut ever AND a positive SPT greater than or equal to 8mm or a CAP-RAST greater than or equal to 15KU/l to peanut

排除标准

  • Children will not be eligible for the study if they have a history of:
  • 1) severe anaphylaxis (as defined by hypotension , collapse, loss of consciousness or hypoxia)
  • 2) Forced Expiratory Volume in 1 Second (FEV1) of <85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)
  • 3) Underlying medical conditions (eg cardiac disease) that increase the risks associated with anaphylaxis
  • 4) Known wheat allergy (the placebo may contain traces of wheat)
  • 5) Use of beta-blockers
  • 6) Inflammatory intestinal conditions, indwelling catheters, gastrostomies or other conditions that may increase the risks of probiotic associated sepsis
  • 7) Cow’s milk allergy, as there may be traces of cow’s milk in the probiotic preparation
  • 8) Already taking probiotics

研究者

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