Probiotics in Metformin Intolerant Patients With Type 2 Diabetes (ProGasMet)
Diabetes Mellitus, Type 2, Metformin Adverse Reaction
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring diabetes type 2, probiotics, metformin intolerance
Eligibility Criteria
Inclusion Criteria:
- Written informed consent for participation in the clinical trial
- Age 18-75 years
- Type 2 diabetes mellitus diagnosed at minimum 6 months prior to the study
- Metformin intolerance defined as gastrointestinal adverse effects occurrence at the daily metformin dose higher than 1500 mg assessed by the Questionnaire adapted from Laura J. McCreight et al., which disappeared or decreased to the accepted tolerable level after dose reduction to 1500 mg per day.
- Metformin treatment in the daily dose not higher than 1500 mg
- Stable metformin dose in the last 3 months before inclusion to the study
Exclusion Criteria:
- Estimated Glomerular Filtration Rate (eGFR) < 60 ml /min/ 1.73m2
- Elevation of ALT and aspartate aminotransferase (AST) activity in the blood serum, three times above the reference value
- Chronic bowel disease
- Any other acute or chronic disease that may cause gastrointestinal symptoms
- Acute or chronic pancreatitis
- Chronic alcohol consumption >30 g/day for men and > 20 g/day for women
- Antibiotic therapy in the last 6 months prior to the study
- Probiotics use in the last 3 months before the study
- Chronic use of steroid drugs or other immunomodulators
- Heart failure (New York Heart Association (NYHA) III and IV)
- Pregnancy or breast feeding
Sites / Locations
- Department of Internal Diseases, Diabetology and Nephrology
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Sanprobi Barrier-multispecies probiotic
carrier material of Sanprobi Barrier-multispecies probiotic
A randomized placebo-controlled, parallel-group study, crossover-design. Intervention: Sanprobi Barrier-multispecies probiotic product, 2,5 x10 9 cfu/gram or placebo, cross-over design
A randomized placebo-controlled, parallel-group study, crossover-design. Intervention: placebo comparator (carrier material of Sanprobi Barrier-multispecies probiotic product , not containing bacterial strains,similar appearance as the probiotic, cross-over design