NL-OMON44814已完成不适用
The role of the intestinal microbiome in enteric and systemic vaccine immune responses - Rota-biome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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
- •* Recent (< 12 months) use of antibiotics (any kind, except for dermal antibiotics)
- •* Known allergy to antibiotics (any kind)
- •* Allergy to any vaccine components (any kind, including allergy to egg white, thiomersal and phenol) or past adverse reaction of any kind to a tetanus or pneumococcal vaccination
- •* Subject has difficulty in donating blood or accessibility of a vein in left or right arm
- •* Subject has donated more than 350 mL of blood in last 3 months
- •* Difficulty swallowing pills
- •* Body mass index >28 kg/m2
- •* Any other issue that, in the opinion of the investigator, could be harmful to the subject or compromise interpretation of the data
研究者
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