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NCT Number: NCT02144948

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

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

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Key information

Conditions

Diabetes Mellitus Type II Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Carus-Hausarztpraxis

Dresden, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

e.-coli-nissle

Drug

1 ml qd for 24 weeks

Other names: Mutaflor

Primary outcomes

  1. Decrease in HbA1c levels

    Time frame: 24 weeks

Secondary outcomes

  1. change in insulin resistance/secretion

    Time frame: 24 weeks

  2. change in lipid parameters

    Time frame: 24 weeks

  3. change in parameters of oxidative stress

    Time frame: 24 weeks

  4. change in gastrointestinal condition

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

GWT-TUD GmbH

Other

Collaborators

  • Ardeypharm GmbH

Registry information

Official study 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

Acronym: PUNiDIA

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 22, 2014
Registry last updated
Feb 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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