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

February 13, 2017 updated by: GWT-TUD GmbH

Pilot Study to Investigate the Effect of E-coli-nissle as Probiotic Adjuvant to Antidiabetic Standard Care in Patients With Diabetes Mellitus Type II

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Carus-Hausarztpraxis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Mutaflor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in HbA1c levels
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
change in insulin resistance/secretion
Time Frame: 24 weeks
24 weeks
change in lipid parameters
Time Frame: 24 weeks
24 weeks
change in parameters of oxidative stress
Time Frame: 24 weeks
24 weeks
change in gastrointestinal condition
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GWT-TUD GmbH

Collaborators

Ardeypharm GmbH

Investigators

  • Principal Investigator: Antje Bergmann, Prof.Dr.med., Carus Hausarztpraxis on behalf of GWT-TUD GmbH
  • Study Chair: Stefan R. Bornstein, Prof.Dr.med, Universitätsklinikum Dresden on behalf of GWT-TUD GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 20, 2014

First Submitted That Met QC Criteria

May 20, 2014

First Posted (Estimate)

May 22, 2014

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUNiDIA-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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