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临床试验/NCT04881773
NCT04881773Unknown不适用

Oral Low Doses Tolerance INduction Study for Peanuts

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
Percentage of patients who reach a tolerated dose

研究概览

简要总结

Several protocols have been proposed in scientifis literature, for oral tolerance induction (OIT) protocols for peanuts. A meta-analysis showed that the data in the literature are rather in favor of the exclusion of peanuts, and that OIT doesn't allow to expect significant levels of peanut protein consumed by the patient, and is associated with an increased risk of anaphylaxis and epinephrine use. Also, in most published protocols, patients with a history of anaphylactic shock, severe asthma, or multiple history of anaphylaxis are excluded.

To date, no protocol has been validated for this type of treatment, and each center follows locally validated schemes. In our unit, the investigators use an OIT protocol that starts at low doses (first dose at 2.68 mg peanut protein) and doses increase is scheduled every 4 to 12 weeks (instead of every 2 weeks). The investigators do not exclude patients with asthma or those with a history of peanut anaphylaxis (grade 2 or 3). The investigators have noted that our protocol is associated with a good safety profile and good efficacy, probably due to the fact that the investigators start at low doses and increase the dose with a prolonged delay, compared to previously published protocols. For this reason, the investigators decided to evaluate the results the investigators obtained in our patients and to better analyze the efficacy and safety profile of our protocol.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Percentage of patients who reach a tolerated dose

时间窗: 24 months

Percentage of patients who reach a tolerated dose of 2000 mg of PP during the ITO and percentage of patients who reach a cumulative tolerated dose of 4400 mg of PP during the oral challenge, carried out at least 6 month after the end of the ITO.

次要结局

  • Percentage of patients experiencing side effects during OIT(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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