NCT02144948

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 14, 2017

Status Verified

August 1, 2015

Enrollment Period

1.4 years

First QC Date

May 20, 2014

Last Update Submit

February 13, 2017

Conditions

Diabetes Mellitus Type II

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

  • Decrease in HbA1c levels

    24 weeks

Secondary Outcomes (4)

  • change in insulin resistance/secretion

    24 weeks

  • change in lipid parameters

    24 weeks

  • change in parameters of oxidative stress

    24 weeks

  • change in gastrointestinal condition

    24 weeks

Study Arms (1)

E.-coli-Nissle

EXPERIMENTAL

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

Drug: e.-coli-nissle

Interventions

e.-coli-nissleDRUG

1 ml qd for 24 weeks

Also known as: Mutaflor
E.-coli-Nissle

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carus-Hausarztpraxis

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Antje Bergmann, Prof.Dr.med.

    Carus Hausarztpraxis on behalf of GWT-TUD GmbH

    PRINCIPAL INVESTIGATOR

  • Stefan R. Bornstein, Prof.Dr.med

    Universitätsklinikum Dresden on behalf of GWT-TUD GmbH

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2014

First Posted

May 22, 2014

Study Start

August 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 14, 2017

Record last verified: 2015-08

Locations

DE(1)