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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Fiber Mix and Glycemic Response

NCT03334643

Type2 Diabetes Mellitus

COMPLETED NA

Safety, Acceptability and Efficacy of a Long-term Intervention With a Diabetes-specific Low-carbohydrate, High-mono-unsaturated Fatty Acid Containing Oral Nutritional Supplement on Glycaemic Control in Type 2 Diabetic Patients

NCT01241695

Diabetes

COMPLETED NA

Type 2 Diabetes and the Effect of Probiotics

NCT00413348

Type 2 Diabetes Healthy Endotoxemia

UNKNOWN NA

Resistant Starch, Gut Bacteria and Diabetes

NCT03057444

Diabetes Mellitus, Type 2 Pre Diabetes

COMPLETED NA

The Use of Statin in Diabetic Patients Not Known to Have Atherosclerotic Cardiovascular Disease

NCT06676683

Diabete Type 2

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus Type II

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

E.-coli-Nissle

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

Group Type EXPERIMENTAL

e.-coli-nissle

Intervention Type DRUG

1 ml qd for 24 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

e.-coli-nissle

1 ml qd for 24 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Mutaflor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No