Dosefinding trial studying effect of 4 weeks Intervention on safety and efficacy in males with Metabolic syndrome treated with oral Eubacterium hallii - DIME

Academisch Medisch Centrum0 个研究点目标入组 27 人开始时间: 待定最近更新: 2024年4月23日

适应症

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•otherwise healthy Caucasian obese subjects with metabolic syndrome (males, aged 21 to 69 years-old; body mass index (BMI) 25 to 43 kg/m2, fasting plasma glucose > 5.6 mmol/l and/or HOMA-IR>2.5, fasting triglycerides > 1.6 mmol/l, waist circumference > 102 cm and not on concomitant medication and regular stool pattern.

•A history of cardiovascular event (myocardial infarction or pacemaker implantation), smoking,cholecystectomy, use of medication including proton pump inhibitors (PPI as this influences intestinal microbiota composition), oral anticoagulants and/or oral antibiotics in the past three months, (expected) prolonged compromised immunity (e.g. due to recent cytotoxic chemotherapy or HIV-infection with a CD4 count < 240). Subjects are also excluded if their levels of plasma aspartate aminotransferase and alanine aminotransferase are 2.5 times or more the upper limit of the normal range; if they have a history of heavy alcohol use (>12 to 15 g of alcohol per day, or >12 oz of beer, 5 oz of wine, or 1.5 oz of distilled spirits); or overt Dm2.

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