Effect of Fecal microbiotA Transplantation combined with MEditerranean Diet on insulin sensitivity in subjects with metabolic syndrome - FATMED

Academisch Medisch Centrum0 个研究点目标入组 36 人开始时间: 待定最近更新: 2024年2月28日

适应症

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•Patients: Male obese (BMI > 30) subjects 21 to 65 years-old
•With at least 3 out of 5 metabolic syndrome criteria (fasting plasma glucose * 5.6 mmol/l, triglycerides * 1.7 mmol/l, waist-circumference > 102 cm, HDL-cholesterol < 1.04 mmol/l, blood pressure * 130/85 mmHg). ;Donors: caucasian, age 18 - 65 years old, BMI 18.5 - 25 kg/m2

•- Use of any medication, including proton pomp inhibitors and antibiotics in the past three months
•- Cholecystectomy
•- A history of cardiovascular event (MI or pacemaker implantation)
•- (expected) prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240).
•- Unmotivated or not able to adhere to a specific diet;Exclusion criteria for donors:
•1. diarrhoea
•2. cholecystectomy
•3. HIV, HAV, HBV, HCV, active CMV, active EBV
•4. Unsafe sex practice (questionnaire)
•5. presence of fecal bacterial pathogens (salmonella, Shigella, Campylobacter, Yersinia) or parasites
•6. positive C. difficile stool test
•7. any medication use including PPI and antibiotics;Individuals with an increased risk for one of the above conditions (homosexual contacts, recent blood transfusions) will be excluded, and donors are not recruited amongst health care providers.

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