This trial is active, not recruiting.

Condition diabetes mellitus type ii
Treatment e.-coli-nissle
Phase phase 3
Sponsor GWT-TUD GmbH
Collaborator ARDEYPHARM GmbH
Start date August 2014
End date August 2015
Trial size 10 participants
Trial identifier NCT02144948, PUNiDIA-2014


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
10 patients will be enrolled Intervention: E.-coli-Nissle (Mutaflor), oral suspension Dose: 1 ml / day frequency: qd
e.-coli-nissle Mutaflor
1 ml qd for 24 weeks

Primary Outcomes

Decrease in HbA1c levels
time frame: 24 weeks

Secondary Outcomes

change in insulin resistance/secretion
time frame: 24 weeks
change in lipid parameters
time frame: 24 weeks
change in parameters of oxidative stress
time frame: 24 weeks
change in gastrointestinal condition
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 45 years up to 80 years old.

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

Additional Information

Official title Pilot Study to Investigate the Effect of E-coli-nissle as Probiotic Adjuvant to Antidiabetic Standard Care in Patients With Diabetes Mellitus Type II
Principal investigator Antje Bergmann, Prof. Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by GWT-TUD GmbH.