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

Diabetes Mellitus Type II Clinical Trial

— PUNiDIA  

Official title:

Pilot Study to Investigate the Effect of E-coli-nissle as Probiotic Adjuvant to Antidiabetic Standard Care in Patients With Diabetes Mellitus Type II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02144948
• Other study ID #: PUNiDIA-2014
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2014
• Last updated: February 13, 2017
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2015
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type II
• Diabetes Mellitus, Type 2

Intervention

Drug:
• e.-coli-nissle
1 ml qd for 24 weeks

Locations

Country	Name	City	State
Germany	Carus-Hausarztpraxis	Dresden

Sponsors (2)

Lead Sponsor	Collaborator
GWT-TUD GmbH	Ardeypharm GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in HbA1c levels		24 weeks
Secondary	change in insulin resistance/secretion		24 weeks
Secondary	change in lipid parameters		24 weeks
Secondary	change in parameters of oxidative stress		24 weeks
Secondary	change in gastrointestinal condition		24 weeks