Status:
COMPLETED
Probiotics in Metformin Intolerant Patients With Type 2 Diabetes
Lead Sponsor:
Medical University of Silesia
Collaborating Sponsors:
Sanprobi Sp. z o.o., Sp. k., Szczecin, Poland
Conditions:
Diabetes Mellitus, Type 2
Metformin Adverse Reaction
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Metformin, the first-line drug in the treatment of type 2 diabetes (T2DM), may cause dose dependent undesirable side-effects like diarrhea, abdominal pain, nausea or bloating which may affect up to 20...
Detailed Description
The optimal daily dose of metformin is thought to be 2000 mg, however patients with metformin intolerance cannot reach this target dose. Participate in this study are metformin intolerant. Metformin i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04089280
Start Date
October 16 2018
End Date
December 31 2021
Last Update
May 6 2022
Active Locations (1)
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1
Department of Internal Diseases, Diabetology and Nephrology
Zabrze, Poland, 41-800