NL-OMON44814
已完成
不适用
The role of the intestinal microbiome in enteric and systemic vaccine immune responses - Rota-biome
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- vaccin immunogeniciteit
- 发起方
- Academisch Medisch Centrum
- 入组人数
- 63
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •\* Healthy, as determined by a responsible physician, based on a medical evaluation including medical history, physical examination and laboratory tests carried out within 28 days prior to starting antibiotics (day \-9\). A subject with a clinical abnormality or laboratory parameter outside the reference range may be included if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures
- •\* Male between 18 and 35 years of age, inclusive at the time of signing the informed consent
- •\* Capable of giving written informed consent and able to comply with the requirements and restrictions listed in the informed consent form
- •\* Normal defecation pattern (defined as \*3x/ day and \*3x/week)
排除标准
- •\* Baseline anti\-rotavirus immunglobluin A level greater than 20 IU/mL or equivalent geometric mean titer.
- •\* Subject has had a major illness in the past 3 months or any significant chronic medical illness that the investigator would deem unfavorable for enrollment, including inflammatory diseases.
- •\* Subject with any history of immunodeficiency
- •Subject with a history of thrombocytopenia or bleeding disorder
- •\* Subjects with a history of any type of malignancy
- •\* Subject has a past or current gastrointestinal disease which may influence the gut microbiota
- •\* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- •\* History of alcoholism and/or drinking more than an average of 5 units of alcohol per day
- •\* The subject has received an investigational product within three months of day 0 of the current study
- •\* Use of prescription or non\-prescription drugs and herbal and dietary supplements within 6 months unless in the opinion of the investigator the medication will not interfere with the study procedures or compromise subject safety
结局指标
主要结局
未指定
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