Trial | NCT02144948  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
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
Study Started
Aug 31
2014
Primary Completion
Jan 31
2016
Study Completion
Jan 31
2016
Last Update
Feb 14
2017

Drug e.-coli-nissle

1 ml qd for 24 weeks

  • Other names: Mutaflor

E.-coli-Nissle Experimental

10 patients will be enrolled Intervention: E.-coli-Nissle (Mutaflor), oral suspension Dose: 1 ml / day frequency: qd

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
No Results Posted