A Randomised, Controlled Trial Evaluating the Effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in Inducing Desensitisation or Remission in Chinese Children With Peanut Allergy Compared With Oral Immunotherapy (OIT) Alone and With Placebo
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs placebo
研究概览
简要总结
At present there is no cure for food allergy. People with a food allergy need to avoid the food they are allergic to in order to stay safe. However we know that accidental exposure is common. Researchers have begun to look at the effectiveness of 'oral immunotherapy' as a treatment for food allergy but results have been mixed.
This study is a randomized controlled trial to evaluate the effectiveness of Probiotic and Peanut Oral Immunotherapy (PPOIT) in inducing tolerance in children with peanut allergy compared with Oral Immunotherapy (OIT) alone and with Placebo. Children will take increasing doses of peanut protein and a set amount of probiotic until a total of 18 months treatment is completed. Children will be tested for peanut allergy at the start of the study, at the end of PPOIT treatment T1 (18 months) and T2 (8 weeks) and T3 (1year) after treatment.
详细描述
This is a three-armed, randomised (4:4:1), stratified (by age), blinded, placebo-controlled, parallel-group, superiority trial.
- PPOIT Probiotic and peanut OIT taken daily for 18 months.
- OIT Probiotic placebo and peanut OIT taken daily for 18 months.
- Placebo Probiotic placebo and OIT placebo taken daily for 18 months.
The study consists of:
Screening visit occurs within three months before Day 1.
Day 1 Rush Induction Phase is the start of treatment where participants receive increasing doses of peanut (or placebo) OIT every 20 minutes to reach a final dose of 12mg of peanut protein (or placebo). A single dose of 2x10^10 cfu Lactobacillus rhamnosus GG (or placebo) is also taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects are eligible if they meet all of the following criteria
- •Aged between 1 year and 17 years of age;
- •>=7kg (the weight considered safe for administration of adrenaline autoinjector (e.g. Jext);
- •Ethnic Chinese; and
- •Confirmed diagnosis of peanut allergy as defined by a failed double-blind placebo-controlled food challenge (DBPCFC) with peanut and a serum peanut-specific IgE level of at least 0.35 kUA (allergen-specific unit) per liter according to ImmunoCAP (Thermo Fisher Scientific) at screening.
排除标准
- •Subjects are not eligible if they meet any of the following criteria
- •History of severe anaphylaxis (as defined by persistent hypotension, collapse, loss of consciousness, persistent hypoxia or ever needing >3 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 >3 doses of intramuscular adrenaline or an intravenous adrenaline infusion for management of an allergic reaction);
- •FEV1 <85% at rest and FEV1/FVC ≤ 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 for anaphylaxis;
- •Use of beta-blockers, and ACE inhibitors;
- •Inflammatory intestinal conditions, indwelling catheters, gastrostomies, immunocompromised states, post-cardiac and/or gastrointestinal tract surgery, critically-ill or other conditions that may increase the risks of probiotic associated sepsis;
- •Already taking probiotic supplements or foods containing probiotics within the past month;
- •Reacting to the placebo component during the study entry DBPCFC;
- •Have received other food immunotherapy treatment in the preceding 12 months;
- •History of suspected or biopsy-confirmed eosinophilic esophagitis (EoE);
- •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); or
- •Non-English and non-Chinese speaking participants and their families. NOTE: participants with other food allergies are NOT excluded from participating in this trial.
结局指标
主要结局
Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs placebo
时间窗: T2 - 8 weeks after final day of maintenance treatment
次要结局
- Peanut SPT wheal size and peanut and peanut component (Ara h 1, Ara h 2, Ara h 3) sIgE and sIgG4 levels in: (i) PPOIT vs placebo; (ii) PPOIT vs OIT; and (iii) OIT vs placebo and their correlation with sustained unresponsiveness.(At 12 months of treatment; T1 - One Day after final day of maintenance treatment. T2 - 8 weeks after final day of maintenance treatment)
- Proportion of participants with 8-week sustained unresponsiveness (passed T1 and T2 challenges) in PPOIT vs peanut OIT.(T2 - 8 weeks after final day of maintenance treatment)
- Proportion of participants who achieve full desensitisation (passed T1 challenge) in: (i) PPOIT vs placebo and (ii) PPOIT vs OIT; and (iii) OIT vs placebo.(T1 - One Day after final day of maintenance treatment)
- The cumulative dose tolerated during the T1 challenge in: (i) PPOIT vs placebo and (ii) PPOIT vs OIT; and (iii) OIT vs placebo.(T1 - One Day after final day of maintenance treatment)
- Exposure-adjusted incidence rate and severity of treatment emergent adverse events (TEAEs) in (i) PPOIT vs placebo; and (ii) PPOIT vs OIT; and (iii) OIT vs placebo groups.(TEAEs will be collected until T2 - 8 weeks after final day of maintenance.)
研究者
Ting-fan Leung
Professor Ting-fan Leung
Chinese University of Hong Kong