NL-OMON48768已完成不适用
Role of bacterioPhages In gut Microbiome composition and glucose metabolism in Metabolic Syndrome subjects - PIMMS
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
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
- •Participants:
- •Caucasian male/female
- •Age: >=18 years old
- •BMI: >=25 kg/m2
- •At least 3 of the following criteria:
- •o Fasting plasma glucose >=5.6 mmol/L OR HOMA-IR index >=2.5
- •o Waist-circumference >=102 cm
- •o HDL cholesterol <=1.02 mmol/L
- •o Blood pressure >=130/85 mmHg
- •o Triglycerides >=1.7 mmol/L
- •Subjects should be able to give informed consent
- •Caucasian male/female
- •Age: >18 years old
- •BMI: 18-25 kg/m2
- •Subjects should be able to give informed consent
排除标准
- •Participants:
- •A history of cardiovascular event (cerebrovascular accident (CVA), myocardial
- •infarction (MI)) or pacemaker implantation
- •Use of any medication including proton pump inhibitors, antibiotics and
- •pro-/prebiotics in the past three months or during the study period
- •(Expected) prolonged compromised immunity (due to recent cytotoxic
- •chemotherapy or human immunodeficiency viruses (HIV) infection with a CD4 count
- •< 240/mm3)
- •Presence of overt type 1 diabetes mellitus (T1DM) or T2D
- •History of 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).
- •Smoking or illicit drug use (MDMA/amphetamine/cocaine/heroin/GHB) in the past
- •three months or use during the study period
- •Use of >5 units of alcohol daily on average in the past three months or use
- •of >2 units of alcohol during the study period
- •History of cholecystectomy
- •Use of any medication including proton pump inhibitors, antibiotics and
- •pro-/prebiotics in the past three months or during the study period
- •History of, or known exposure to HIV, hepatitis B (HBV) or C virus (HCV),
- •syphilis, human T-lymphotropic virus (HTLV) I and II, malaria, trypanosomiasis,
- •tuberculosis
- •Known systemic infection not controlled at the time of donation
- •Smoking or illicit drug use (MDMA/amphetamine/cocaine/heroin/GHB) in the past
- •three months or use during the study period
- •Use of >5 units of alcohol daily on average in the past three months or use
- •of >2 units of alcohol during the study period
- •Risky sexual behaviour (anonymous sexual contacts; sexual contacts with
- •prostitutes, drug addicts, individuals with HIV, viral hepatitis, syphilis;
- •work as prostitute; history of sexually transmittable disease)
- •Previous reception of tissue/organ transplant
- •Previous (<12 months) reception of blood products
- •Recent (<6 months) needle stick accident
- •Recent (<6 months) body tattoo, piercing, earring, acupuncture
- •Recent medical treatment in poorly hygienic conditions
- •Risk of transmission of diseases caused by prions
- •Recent parasitosis or infection from rotavirus, Giardia lamblia and other
- •microbes with GI involvement
- •Recent (<6 months) travel in tropical countries, countries at high risk of
- •communicable diseases or traveller's diarrhoea
- •Recent (<6 months) history of vaccination with a live attenuated virus, if
- •there is a possible risk of transmission
- •Healthcare providers having frequent patient contact (to exclude the risk of
- •transmission of multidrug-resistant organisms)
- •Individual working with animals (to exclude the risk of transmission of
- •zoonotic infections)
- •History of IBS (according to Rome IV criteria), IBD, functional chronic
- •constipation, coeliac disease, other chronic GI disorders
- •History of chronic, systemic autoimmune disorders with GI involvement
- •History of, or high risk for, GI cancer or polyposis
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研究者
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