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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02144948
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : February 14, 2017
Ardeypharm GmbH
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type II Drug: e.-coli-nissle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: E.-coli-Nissle
10 patients will be enrolled Intervention: E.-coli-Nissle (Mutaflor), oral suspension Dose: 1 ml / day frequency: qd
Drug: e.-coli-nissle
1 ml qd for 24 weeks
Other Name: Mutaflor

Primary Outcome Measures :
  1. Decrease in HbA1c levels [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. change in insulin resistance/secretion [ Time Frame: 24 weeks ]
  2. change in lipid parameters [ Time Frame: 24 weeks ]
  3. change in parameters of oxidative stress [ Time Frame: 24 weeks ]
  4. change in gastrointestinal condition [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02144948

Dresden, Germany, 01307
Sponsors and Collaborators
Ardeypharm GmbH
Principal Investigator: Antje Bergmann, Carus Hausarztpraxis on behalf of GWT-TUD GmbH
Study Chair: Stefan R. Bornstein, Universitätsklinikum Dresden on behalf of GWT-TUD GmbH

Responsible Party: GWT-TUD GmbH Identifier: NCT02144948     History of Changes
Other Study ID Numbers: PUNiDIA-2014
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: August 2015

Keywords provided by GWT-TUD GmbH:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases