ACTRN12619000480189进行中（未招募）2 期
A phase 2, dual-centre, randomised, controlled trial evaluating the effectiveness of probiotic and egg oral immunotherapy at inducing desensitisation or sustained unresponsiveness (remission) in participants with egg allergy compared with placebo (Probiotic Egg Allergen Oral Immunotherapy for Treatment of Egg Allergy: PEAT study).
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 41
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
- 5 Years 至 30 Years（—）
- 性别
- All
入选标准
- •Subjects are eligible for the study if they meet all of the following criteria:
- •- Aged between 5 and 30 years of age
- •- Confirmed diagnosis of egg allergy as defined by a failed DBPCFC and a positive SPT or sIgE to egg at screening
排除标准
- •Subjects are not eligible for the study if they meet any of the following criteria:
- •Subjects who are on an egg ladder diet (except baked egg)
- •History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing more than three (3) doses of intramuscular adrenaline (epinephrine) or an intravenous adrenaline (epinephrine) 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 more than 3 doses of intramuscular adrenaline (epinephrine) or an intravenous adrenaline (epinephrine) infusion for management of an allergic reaction)
- •FEV1 less than 85% predicted at rest and FEV1/FVC is less than or equal to 85% predicted at rest (for those participants able to perform spirometry testing) 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 or food containing probiotics in the last month.
- •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
- •History of suspected or biopsy-confirmed eosinophilic oesophagitis (EoE)
- •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)
- •Non-English speaking participants and families
- •Participants 18 years or over (RCH site only)
- •NOTE: participants with other food allergies are NOT excluded from participating in this trial.
研究者
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