Investigation of the effect of E.-coli-Nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type 2

pilot study to investigate the effect of e.-coli-nissle as probiotic adjuvant to antidiabetic standard care in patients with diabetic mellitus type 2 - PUNiDIA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-000936-40-DE

Enrollment

Unknown

Registered

2014-05-06

Start date

2014-06-26

Completion date

Unknown

Last updated

2017-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus type 2 MedDRA version: 17.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Mutaflor Product Name: Mutaflor Pharmaceutical Form: Oral suspension INN or Proposed INN: ESCHERICHIA COLI NISSLE 1917 Other descriptive name: ESCHERICHIA COLI STRAIN NISSLE 1917 Concentra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Diabetes mellitus type 2 - HbA1c >7% (stable for 6 months) - oral antidiabetic therapie for 6 months with Metformin, Vildagliptin, Gliniden or without Oral antidiabetic medication - age between 45 and 80 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: -Myocardial infarction or stroke within the last 5 years - insulin therapy -Therapy with arcabose -Acute periphere arterial disease within the last 12 months -Insable 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Decrease in HbA1c levels within baseline and end of treatment;Secondary Objective: -change in insulin resistance/secretion - change in lipid parameters - change in parameters of oxidative stress - change in parameters of inflammation - change in gastrointestinal condition - tolerance of therapy;Primary end point(s): Decrease in HbA1c levels within baseline and end of treatment;Timepoint(s) of evaluation of this end point: for patients: 26 weeks (2 weeks screening phase + 24 weeks treatment phase) for trial: 12 months	—

Measure

Time frame

Main Objective: Decrease in HbA1c levels within baseline and end of treatment;Secondary Objective: -change in insulin resistance/secretion - change in lipid parameters - change in parameters of oxidative stress - change in parameters of inflammation - change in gastrointestinal condition - tolerance of therapy;Primary end point(s): Decrease in HbA1c levels within baseline and end of treatment;Timepoint(s) of evaluation of this end point: for patients: 26 weeks (2 weeks screening phase + 24 weeks treatment phase) for trial: 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): -change in insulin resistance/secretion - change in lipid parameters - change in parameters of oxidative stress - change in parameters of inflammation - change in gastrointestinal condition - tolerance of treatment;Timepoint(s) of evaluation of this end point: for patients: 26 weeks (2 weeks screening phase + 24 weeks treatment phase) for trial: 12 months	—

Countries

Germany

Contacts

Public ContactMedical Consulting

GWT-TUD GmbH

medical.consulting@gwtonline.de0049035125933100

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026