Investigation of the Effect of E.-Coli-Nissle as Supporting Therapy to Standard Care of Diabetes Mellitus Type II
Phase 3
Completed
- Conditions
- Diabetes Mellitus Type II
- Interventions
- Drug: e.-coli-nissle
- Registration Number
- NCT02144948
- Lead Sponsor
- GWT-TUD GmbH
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description E.-coli-Nissle e.-coli-nissle 10 patients will be enrolled Intervention: E.-coli-Nissle (Mutaflor), oral suspension Dose: 1 ml / day frequency: qd
- Primary Outcome Measures
Name Time Method Decrease in HbA1c levels 24 weeks
- Secondary Outcome Measures
Name Time Method change in insulin resistance/secretion 24 weeks change in parameters of oxidative stress 24 weeks change in lipid parameters 24 weeks change in gastrointestinal condition 24 weeks
Trial Locations
- Locations (1)
Carus-Hausarztpraxis
🇩🇪Dresden, Germany