Back to results

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

Primary Purpose

Diabetes Mellitus Type II

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

e.-coli-nissle

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type II focused on measuring diabetes

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Carus-Hausarztpraxis

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

E.-coli-Nissle

Arm Description

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

Outcomes

Primary Outcome Measures

Decrease in HbA1c levels

Secondary Outcome Measures

change in insulin resistance/secretion

change in lipid parameters

change in parameters of oxidative stress

change in gastrointestinal condition

Full Information

NCT ID

NCT02144948

First Posted

May 20, 2014

Last Updated

February 13, 2017

Sponsor

GWT-TUD GmbH

Collaborators

Ardeypharm GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02144948

Brief Title

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

Acronym

PUNiDIA

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 Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

August 2014 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GWT-TUD GmbH

Collaborators

Ardeypharm GmbH

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type II

Keywords

diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

E.-coli-Nissle

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

e.-coli-nissle

Other Intervention Name(s)

Mutaflor

Intervention Description

1 ml qd for 24 weeks

Primary Outcome Measure Information:

Title

Decrease in HbA1c levels

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

change in insulin resistance/secretion

Time Frame

24 weeks

Title

change in lipid parameters

Time Frame

24 weeks

Title

change in parameters of oxidative stress

Time Frame

24 weeks

Title

change in gastrointestinal condition

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antje Bergmann, Prof.Dr.med.

Organizational Affiliation

Carus Hausarztpraxis on behalf of GWT-TUD GmbH

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stefan R. Bornstein, Prof.Dr.med

Organizational Affiliation

Universitätsklinikum Dresden on behalf of GWT-TUD GmbH

Official's Role

Study Chair

Facility Information:

Facility Name

Carus-Hausarztpraxis

City

Dresden

ZIP/Postal Code

01307

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs