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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GWT-TUD GmbH
• Collaborator: Ardeypharm GmbH

Criteria

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