NL-OMON51538已完成不适用
Effect of a probiotic strain on immune response to influenza vaccination - VERB Study
ADM Biopolis0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
- 16 至 64（—）
入选标准
- •1. Age >=16 and <=65
- •2. Self-reported regular Dutch eating habits as assessed by questionnaire (3
- •main meals per day)
- •3. Non-smokers (ex-smokers can participate if they stopped at least 6 months
- •before screening)
- •4. BMI >=18.5 and <=28
- •5. In good health as assessed during screening, and the medical investigator*s
- •professional judgment
- •6. Adherence to habitual diet, no changes during study period
- •7. Signed informed consent
排除标准
- •1. Influenza vaccination within 6 months before the start of the intervention
- •2. Any vaccination in the month before randomization (visit 1) or any scheduled
- •vaccination during the study period
- •3. Self-reported influenza infection within 6 months before the start of the
- •intervention
- •4. Acute infection (including gastroenteritis) within 2 months before start of
- •the intervention
- •5. Treatment with oral antibiotics within 2 months before the start of the
- •intervention
- •6. Serious progressive disease or non-stabilized chronic illness (e.g.,
- •diabetes mellitus, cardiac insufficiency, respiratory insufficiency, cancer,
- •chronic kidney or liver disease)
- •7. Gastrointestinal disorders (e.g., inflammatory bowel disease)
- •8. Immunodeficiency or autoimmune disorder
- •9. Use of immunosuppressive drugs (e.g. cyclosporine, azathioprine, systemic
- •corticosteroids, antibodies)
- •10. Unexplained weight loss or weight gain of > 3 kg in the 3 months prior to
- •pre-study screening
- •11. Evidence of current excessive alcohol consumption (>4 consumptions/day or
- •>20 consumptions/week) or drug (ab)use
- •12. No change in use of immune boosting supplements during the study
- •13. Mental status that is incompatible with the proper conduct of the study
研究者
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