TY - JOUR
T1 - Clinical Trial
T2 - Probiotics in Metformin Intolerant Patients with Type 2 Diabetes (ProGasMet)
AU - Nabrdalik, Katarzyna
AU - Drożdż, Karolina
AU - Kwiendacz, Hanna
AU - Skonieczna-Żydecka, Karolina
AU - Łoniewski, Igor
AU - Kaczmarczyk, Mariusz
AU - Wijata, Agata M.
AU - Nalepa, Jakub
AU - Holleman, Frits
AU - Nieuwdorp, Max
AU - Gumprecht, Janusz
N1 - Funding Information: This study was supported by 2020 research grant from the Diabetes Poland as a research project entitled " Diabetes Poland Competition for scientific grant " and by statutory finances of Medical University of Silesia (PCN-1–176/N/9/K). AMW and JN were supported by the Silesian University of Technology funds through the Excellence Initiative – Research University program (grant 02/080/SDU/10–21–01 ). AMW was partially supported by the Silesian University of Technology funds through the grant for maintaining and developing research potential. The probiotics were donated by a distributor of probiotic formulas Sanprobi sp. z o. o. sp. k. The funding sources had no role in the study design, data collection, interpretation of analysis, writing of the manuscript, or decision to submit the publication. Publisher Copyright: © 2023
PY - 2023/12/1
Y1 - 2023/12/1
N2 - Background: For decades, metformin has been the drug of first choice in the management of type 2 diabetes. However, approximately 2–13% of patients do not tolerate metformin due to gastrointestinal (GI) side effects. Since metformin influences the gut microbiota, we hypothesized that a multi-strain probiotics supplementation would mitigate the gastrointestinal symptoms associated with metformin usage. Methods and analysis: This randomized, double-blind, placebo-controlled, single-center, cross-over trial (ProGasMet study) assessed the efficacy of a multi-strain probiotic in 37 patients with metformin intolerance. Patients were randomly allocated (1:1) to receive probiotic (PRO-PLA) or placebo (PLA-PRO) at baseline and, after 12 weeks (period 1), they crossed-over to the other treatment arm (period 2). The primary outcome was the reduction of GI adverse events of metformin. Results: 37 out of 82 eligible patients were enrolled in the final analysis of whom 35 completed the 32 weeks study period and 2 patients resigned at visit 5. Regardless of the treatment arm allocation, while on probiotic supplementation, there was a significant reduction of incidence (for the probiotic period in PRO-PLA/PLA-PRO: P = 0.017/P = 0.054), quantity and severity of nausea (P = 0.016/P = 0.024), frequency (P = 0.009/P = 0.015) and severity (P = 0.019/P = 0.005) of abdominal bloating/pain as well as significant improvement in self-assessed tolerability of metformin (P < 0.01/P = 0.005). Moreover, there was significant reduction of incidence of diarrhea while on probiotic supplementation in PRO-PLA treatment arm (P = 0.036). Conclusion: A multi-strain probiotic diminishes the incidence of gastrointestinal adverse effects in patients with type 2 diabetes and metformin intolerance.
AB - Background: For decades, metformin has been the drug of first choice in the management of type 2 diabetes. However, approximately 2–13% of patients do not tolerate metformin due to gastrointestinal (GI) side effects. Since metformin influences the gut microbiota, we hypothesized that a multi-strain probiotics supplementation would mitigate the gastrointestinal symptoms associated with metformin usage. Methods and analysis: This randomized, double-blind, placebo-controlled, single-center, cross-over trial (ProGasMet study) assessed the efficacy of a multi-strain probiotic in 37 patients with metformin intolerance. Patients were randomly allocated (1:1) to receive probiotic (PRO-PLA) or placebo (PLA-PRO) at baseline and, after 12 weeks (period 1), they crossed-over to the other treatment arm (period 2). The primary outcome was the reduction of GI adverse events of metformin. Results: 37 out of 82 eligible patients were enrolled in the final analysis of whom 35 completed the 32 weeks study period and 2 patients resigned at visit 5. Regardless of the treatment arm allocation, while on probiotic supplementation, there was a significant reduction of incidence (for the probiotic period in PRO-PLA/PLA-PRO: P = 0.017/P = 0.054), quantity and severity of nausea (P = 0.016/P = 0.024), frequency (P = 0.009/P = 0.015) and severity (P = 0.019/P = 0.005) of abdominal bloating/pain as well as significant improvement in self-assessed tolerability of metformin (P < 0.01/P = 0.005). Moreover, there was significant reduction of incidence of diarrhea while on probiotic supplementation in PRO-PLA treatment arm (P = 0.036). Conclusion: A multi-strain probiotic diminishes the incidence of gastrointestinal adverse effects in patients with type 2 diabetes and metformin intolerance.
KW - Diabetes mellitus type 2
KW - Metformin intolerance
KW - Probiotics
UR - http://www.scopus.com/inward/record.url?scp=85173138267&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.biopha.2023.115650
DO - https://doi.org/10.1016/j.biopha.2023.115650
M3 - Article
C2 - 37812890
SN - 0753-3322
VL - 168
JO - Biomedicine and Pharmacotherapy
JF - Biomedicine and Pharmacotherapy
M1 - 115650
ER -