ACTRN12616000322437已完成未知
A multicentre, randomized, controlled trial evaluating the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing desensitisation or tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with placebo.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 201
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 meet all of these criteria:
- •- Children aged between 1 year and 10 years of age
- •- greater than 7kg (the weight considered safe for the administration of an Epipen/EpiPen Jr)
- •- Confirmed diagnosis of peanut allergy as defined by a failed Double-Blind, Placebo-Controlled Food Challenge (CBPCFC) with peanut and a positive SPT or SIgE to peanut at screening.
排除标准
- •Children are not eligible for the study if they meet any of these criteria:
- •- History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
- •- Severe anaphylaxis during the study entry DBPCFC (defined as persistent hypotension, collapse, loss of consciousness, persistent hypoxia, or requiring three or more doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction)
- •- FEV1 less than 85% at rest and FEV1/FVC is less than or equal to 85% at rest or ongoing chronic persistent asthma (as per Australian Asthma Foundation guidelines)
- •- Underlying medical conditions (e.g. cardiac disease) that increase the risks associated with anaphylaxis
- •- Use of beta-blockers, and ACE inhibitors
- •- Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immune-compromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill and those requiring prolonged hospitalisation or other conditions that may increase the risks of probiotic associated sepsis
- •- Already taking probiotic supplements within the past 6 months (does not include formula)
- •- Reacting to the placebo component during the study entry DBPCFC
- •- Have received other food immunotherapy treatment in the preceding 12 months
- •- Currently taking immunomodulatory therapy (including allergen immunotherapy)
- •- Past or current major illness that in the opinion of the Site Investigator may affect the subject’s ability to participate in the study e.g. increased risk to the participant
- •- Subjects who in the opinion of the Site Investigator are unable to follow the protocol
- •- Another family member already enrolled in the trial (to maintain safety and blinding)
研究者
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