NL-OMON53774已完成不适用
Safety and Viability of an E. coli Nissle Colibactin Knockout in Healthy Volunteers: A Randomised Controlled Safety Study - SECONI
Amsterdam UMC0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
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 64（—）
入选标准
- •- Healthy male or female of Caucasian descent
- •o If female, postmenopausal
- •- Age: 18-65 years old
- •- BMI: 18-25 kg/m2
- •- Subjects should be able to give informed consent
排除标准
- •- Use of any systemic medication (except for paracetamol), including proton
- •pump inhibitors, antibiotics and pro-/prebiotics in the past three months or
- •during the study period.
- •- Use of the EcN probiotic strain (Mutaflor®) in the past 12 months.
- •- (Expected) prolonged comprised immunity (e.g. due to recent cytotoxic
- •chemotherapy or human immunodeficiency viruses (HIV) infection with a CD4 count
- •< 240/mm3).
- •- History of moderate to severe disease of the digestive tract, such as
- •celiac disease, chronic diarrhoea (>=3 stools/day for >4 weeks), chronic
- •obstipation (<2 defecations/week for >3 months), Irritable Bowel Syndrome (IBS)
- •(according to Rome IV criteria) or Inflammatory Bowel Disease (IBD).
- •- Any gastro-intestinal disorder within the past 6 months
- •- Smoking or illicit drug use (e.g. MDMA/amphetamine/cocaine/heroin/GHB) in the
- •past three months or use during the study period.
- •- Use of >21 units of alcohol per week on average in the past three months or
- •use of >2 units of alcohol during the study period.
- •- Pregnancy or breast feeding
- •- Simultaneous participation in other studies
研究者
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