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

GWT-TUD

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus Type II

Treatments: Drug: e.-coli-nissle

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02144948

PUNiDIA-2014

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

E.-coli-Nissle

Experimental group

Description:

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

Treatment:

Drug: e.-coli-nissle