Clinical trial: Probiotics in Metformin Intolerant Patients With Type 2 Diabetes (NCT04089280)

Eligibility criteria:
Inclusion Criteria:

          1. Written informed consent for participation in the clinical trial

          2. Age 18-75 years

          3. Type 2 diabetes mellitus diagnosed at minimum 6 months prior to the study

          4. 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.

          5. Metformin treatment in the daily dose not higher than 1500 mg

          6. Stable metformin dose in the last 3 months before inclusion to the study

        Exclusion Criteria:

          1. Estimated Glomerular Filtration Rate (eGFR) < 60 ml /min/ 1.73m2

          2. Elevation of ALT and aspartate aminotransferase (AST) activity in the blood serum,
             three times above the reference value

          3. Chronic bowel disease

          4. Any other acute or chronic disease that may cause gastrointestinal symptoms

          5. Acute or chronic pancreatitis

          6. Chronic alcohol consumption >30 g/day for men and > 20 g/day for women

          7. Antibiotic therapy in the last 6 months prior to the study

          8. Probiotics use in the last 3 months before the study

          9. Chronic use of steroid drugs or other immunomodulators

         10. Heart failure (New York Heart Association (NYHA) III and IV)

         11. Pregnancy or breast feeding
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? 1