The food diary includes hours of meals, the weight of products and dishes, and the amount of fluids consumed during the day. This is why the investigators hypothesize that it may also reduce the intensity of adverse effects associated with metformin use. Visit 7 - month 5 (4 weeks ± 3 days from the visit 6) Gastrointestinal symptoms questionnaire administration. For morphological tests (blood count with smear, lipid profile, fasting glucose, C-reactive protein and ionogram) at the third visit for each competitor was collected blood from the vein in the amount of 10 ml.

The intervention factor was the SANPROBI BARRIER multi-strain probiotic (commonly available in pharmacies) or placebo (created on the model of a probiotic capsule, specially for the needs of research, by Sanprobi Sp. z o.o.). Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactococcus lactis W19, Lactococcus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Lactobacillus salivarius W24. Statistical analysis will be performed according to the E9 Statistical Principles for Clinical Trials [ 80]. For quantitative outcomes, the between-group comparisons will be performed using the ANOVA or Kruskal-Wallis rank-based nonparametric test depending on the data distribution followed by appropriate post-hoc tests. The qualitative outcomes will be compared using the Chi-square test. Longitudinal data will be analyzed with either repeated measures of ANOVA or aligned rank-transform ANOVA, depending on the data distribution, or McNemar’s test.

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kapsułka zawiera 1×10 10 CFU/g całkowitej liczba bakterii probiotycznych Lactobacillus paracasei 8700:2, Lactobacillus plantarum HEAL 9 i Lactobacillus plantarum HEAL 19 oraz 1,5 µg witaminy D3; Jej zadaniem jest ograniczenie przenikania do krwi bakterii patogennych oraz produkowanych przez nie toksycznych metabolitów. Rena G, Hardie DG, Pearson ER. The mechanisms of action of metformin. Diabetologia. 2017 Sep;60(9):1577-1585. doi: 10.1007/s00125-017-4342-z. Epub 2017 Aug 3.

de Roos NM, Giezenaar CG, Rovers JM, Witteman BJ, Smits MG, van Hemert S. The effects of the multispecies probiotic mixture Ecologic(R)Barrier on migraine: results of an open-label pilot study. Benef Microbes. 2015;6(5):641-6. doi: 10.3920/BM2015.0003. Epub 2015 Apr 22. The following parameters were assessed: body weight (kg), body fat content in kilograms and percent, visceral fat content (cm2), skeletal muscle mass (kg), body water content (kg).To the best of our knowledge, this will be the first intervention study assessing the efficacy of both probiotic supplementation and a gluten-free diet and comparing the effect of both interventions and their combination in MDD patients. The protocol and the outline were developed by a multidisciplinary researcher team. The methodology employed in the study benefited greatly from our diverse set of knowledge, experience and perspectives. Considering the highly rigoristic selection criteria, the participant group is relatively large. Rigorous procedures established for this trial will be followed by well-trained researchers to ensure that research will be conducted in accordance with standards of best practice. The measurements listed above will be introduced to reduce the potential bias related to confounding variables (e.g. smoking, physical activity, and diet).