Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II

Pilot Study to Investigate the Effect of E-coli-nissle as Probiotic Adjuvant to Antidiabetic Standard Care in Patients With Diabetes Mellitus Type II

This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type II

Inclusion Criteria:

• diabetes mellitus type 2;
• HbA1c >7 % (stable für 6 months, max. variation of 0,5%)
• stable oral antidiabetic therapy for 6 months with Metformin, Vildagliptin, Gliniden or without oral Antidiabetics
• age of 45 to <80 years (men and women)

Exclusion Criteria:

• Myocardial infarction or stroke within the last 5 years
• Therapy with acarbose
• Acute peripheral arterial disease within the last 12 months
• Instable metabolic situation
• Uncontrolled hypertension
• Body-Mass-Index ≥ 35 kg/m²
• Smokers
• Daily consumption of probiotic food
• Malignant disease within the last 5 years
• Status post transplantation
• Immunosuppressive therapy within the last 3 months
• Therapy with antibiotics
• Macroalbuminuria
• Severe liver disease