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

Diabetes Mellitus, Type 2

Metformin Adverse Reaction

Multi-strain probiotic Sanprobi Barrier (Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus lactis W19, Lactobacillus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Lactobacillus salivarius W24) or placebo. Patients will be randomized to one of the two products ("A" or "B") each containing probiotic/placebo and administered for 12 weeks. After 12 weeks of supplementation, the probiotic/placebo product "A" or "B" will be discontinued and reintroduced again after next 4 weeks - patients will be switched to the other "A or B" group of probiotic/placebo arm. Patients will be administered with 4 capsules per day for 24 weeks (12 weeks for group A probiotic/placebo and 12 weeks for group B probiotic/placebo allowing 4 weeks washout between the group assignment).

Sanprobi Barrier-multispecies probiotic

Carrier material of Sanprobi Barrier-multispecies probiotic product, not containing bacterial strains,similar appearance as the probiotic

Placebo Comparator

Department of Internal Diseases, Diabetology and Nephrology

Probiotics in Metformin Intolerant Patients With Type 2 Diabetes

The Effect of Multi-strain Probiotics on Gastrointestinal Symptoms in Patients With Type 2 Diabetes and Metformin Intolerance. A 32-week Prospective, Single Center, Randomized, Placebo Controlled, Cross-over Clinical Trial.

Questionnaire to Assess Character and Severity of Metformin Intolerance (adapted from Laura J. Mc Creight et al.). The score indicates how the patient tolerates metformin.
Score interpretation:
0 - 10 = tolerant (T) 11-20 = mild intolerance (MI) 21-30 = intolerant (I) 31-50 = severely intolerant (SI)

assessment of short chain fatty acids in stool (gas chromatography)

Medical University of Silesia

Sanprobi Sp. z o.o., Sp. k., Szczecin, Poland

prospective, single center , interventional

Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days

Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days

Helicobacter Pylori Infection

Omeprazole 20mg

Esomeprazole 20mg

Rabeprazole Sodium 20mg

Vonoprazan

Clinical Trials & Research Unit

A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis

A Randomized Controlled Trial of Triple Therapy With Conventional Proton Pump Inhibitor vs Triple Therapy With Vonoprazan as First Line Therapy for Helicobacter Pylori Gastritis

Compare eradication rates of Helicobacter pylori by triple therapy with conventional proton pump inhibitor (Omeprazole/ Esomeprazole/ Rabeprazole) (TTP regimen) vs triple therapy with Vonoprazan (TTV regimen) in a multi-racial Asian cohort, using Carbon-13 urea breath test or biopsy

Evaluate the prevalence of antibiotic (clarithromycin/ amoxicillin/ levofloxacin/ tetracycline) resistance in H. pylori-infected patients of both treatment groups using E-test

Assess the safety of triple therapy for eradication of H. pylori in the local population using adverse effect questionnaire

Perform CYP2C19 using sequencing or restriction fragment length polymorphism methods

Ang Shih Wen Daphne

Senior Consultant

Changi General Hospital

Diagnosed H. pylori positive patients (n=252) will be randomized into four study groups:
Group A: Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days (n=42)
Group B: Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days (n=42)
Group C: Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days(n=42)
Group D: Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days (n=42)

catalase/nausea

Probiotics in Metformin Intolerant Patients With Type 2 Diabetes

A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis

Opioid-Redox Study

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