Investigation of the Effect of E.-Coli-Nissle as Supporti... | NCT02144948

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

NCT02144948

Sponsor

GWT-TUD GmbH

Status

Completed

Last Update Posted

Feb 14, 2017Actual

Enrollment

10Actual

Phase

Phase 3

Conditions

Diabetes Mellitus Type II

Interventions

e.-coli-nissle

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

May 20, 2014

First Submission Date that Met QC Criteria

May 20, 2014

First Posted Date

May 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2017

Last Update Posted Date

Feb 14, 2017Actual

Name	Class
Ardeypharm GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
e.-coli-nissle	Drug	1 ml qd for 24 weeks	E.-coli-Nissle	Mutaflor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease in HbA1c levels		24 weeks

Secondary Outcomes

Measure	Description	Time Frame
change in insulin resistance/secretion		24 weeks
change in lipid parameters		24 weeks
change in parameters of oxidative stress

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carus-Hausarztpraxis		Dresden		01307	Germany

Type	Date	Date Unknown
Release	Sep 12, 2018
Reset	Feb 14, 2019
Release	Apr 26, 2022
Reset	Jan 27, 2023
Release	Feb 20, 2023
Reset	Nov 20, 2023
Release	Sep 24, 2024
Reset	Sep 27, 2024

Submission Tracking

Estimated Results First Submitted Date

Sep 12, 2018

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 12, 2018			Feb 14, 2019
Apr 26, 2022

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided