دورية أكاديمية
Clinical Trial:Probiotics in Metformin Intolerant Patients with Type 2 Diabetes (ProGasMet)
| العنوان: | Clinical Trial:Probiotics in Metformin Intolerant Patients with Type 2 Diabetes (ProGasMet) |
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| المؤلفون: | Nabrdalik, Katarzyna, Drożdż, Karolina, Kwiendacz, Hanna, Skonieczna-Żydecka, Karolina, Łoniewski, Igor, Kaczmarczyk, Mariusz, Wijata, Agata M., Nalepa, Jakub, Holleman, Frits, Nieuwdorp, Max, Gumprecht, Janusz |
| المصدر: | Nabrdalik , K , Drożdż , K , Kwiendacz , H , Skonieczna-Żydecka , K , Łoniewski , I , Kaczmarczyk , M , Wijata , A M , Nalepa , J , Holleman , F , Nieuwdorp , M & Gumprecht , J 2023 , ' Clinical Trial : Probiotics in Metformin Intolerant Patients with Type 2 Diabetes (ProGasMet) ' , Biomedicine and Pharmacotherapy , vol. 168 , 115650 . https://doi.org/10.1016/j.biopha.2023.115650Test |
| سنة النشر: | 2023 |
| الوصف: | 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://research.vumc.nl/en/publications/f853332a-90ec-4ace-8e6b-d759a6ee1cbbTest |
| DOI: | 10.1016/j.biopha.2023.115650 |
| الإتاحة: | https://doi.org/10.1016/j.biopha.2023.115650Test https://research.vumc.nl/en/publications/f853332a-90ec-4ace-8e6b-d759a6ee1cbbTest http://www.scopus.com/inward/record.url?scp=85173138267&partnerID=8YFLogxKTest |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.9B98D83B |
| قاعدة البيانات: | BASE |
| DOI: | 10.1016/j.biopha.2023.115650 |
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