Effect of probiotics, Bifidobacterium bifidum G9-1, on gastrointestinal symptoms in patients with type 2 diabetes mellitus: study protocol for open-label, single-arm, exploratory research trial (Big STAR study)
Metformin is associated with risks of gastrointestinal complications in patients with type 2 diabetes. In contrast, probiotic Bifidobacterium bifidum G9-1 (BBG9-1) could improve the symptoms of diarrhea caused by metformin in animal models. Thus, the primary outcome of this study will be the effect...
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| Published in | Journal of Clinical Biochemistry and Nutrition Vol. 67; no. 3; pp. 223 - 227 |
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| Abstract | Metformin is associated with risks of gastrointestinal complications in patients with type 2 diabetes. In contrast, probiotic Bifidobacterium bifidum G9-1 (BBG9-1) could improve the symptoms of diarrhea caused by metformin in animal models. Thus, the primary outcome of this study will be the effect of the probiotic BBG9-1 on gastrointestinal symptoms, including diarrhea, in patients with type 2 diabetes who use metformin. This open-label, single-arm, and exploratory study will examine 40 patients with type 2 diabetes who use metformin and have symptoms of constipation or diarrhea. After the baseline examination (objective 1), patients will be administered probiotic BBG9-1 for 10 ± 2 weeks. Then, examinations will be performed (objective 2). The primary outcome will be changes in the symptoms of constipation or diarrhea from objective 1 to objective 2. Secondary outcomes will include changes in gut microbiota, and correlations between changes in fecal properties and biomarkers, including HbA1c level and body mass index. This is the first study to investigate the effect of probiotic BBG9-1 on the change in the symptom of constipation or diarrhea in patients with type 2 diabetes who use metformin. |
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| AbstractList | Metformin is associated with risks of gastrointestinal complications in patients with type 2 diabetes. In contrast, probiotic
Bifidobacterium bifidum
G9-1 (BBG9-1) could improve the symptoms of diarrhea caused by metformin in animal models. Thus, the primary outcome of this study will be the effect of the probiotic BBG9-1 on gastrointestinal symptoms, including diarrhea, in patients with type 2 diabetes who use metformin. This open-label, single-arm, and exploratory study will examine 40 patients with type 2 diabetes who use metformin and have symptoms of constipation or diarrhea. After the baseline examination (objective 1), patients will be administered probiotic BBG9-1 for 10 ± 2 weeks. Then, examinations will be performed (objective 2). The primary outcome will be changes in the symptoms of constipation or diarrhea from objective 1 to objective 2. Secondary outcomes will include changes in gut microbiota, and correlations between changes in fecal properties and biomarkers, including HbA1c level and body mass index. This is the first study to investigate the effect of probiotic BBG9-1 on the change in the symptom of constipation or diarrhea in patients with type 2 diabetes who use metformin. Metformin is associated with risks of gastrointestinal complications in patients with type 2 diabetes. In contrast, probiotic Bifidobacterium bifidum G9-1 (BBG9-1) could improve the symptoms of diarrhea caused by metformin in animal models. Thus, the primary outcome of this study will be the effect of the probiotic BBG9-1 on gastrointestinal symptoms, including diarrhea, in patients with type 2 diabetes who use metformin. This open-label, single-arm, and exploratory study will examine 40 patients with type 2 diabetes who use metformin and have symptoms of constipation or diarrhea. After the baseline examination (objective 1), patients will be administered probiotic BBG9-1 for 10 ± 2 weeks. Then, examinations will be performed (objective 2). The primary outcome will be changes in the symptoms of constipation or diarrhea from objective 1 to objective 2. Secondary outcomes will include changes in gut microbiota, and correlations between changes in fecal properties and biomarkers, including HbA1c level and body mass index. This is the first study to investigate the effect of probiotic BBG9-1 on the change in the symptom of constipation or diarrhea in patients with type 2 diabetes who use metformin. Metformin is associated with risks of gastrointestinal complications in patients with type 2 diabetes. In contrast, probiotic Bifidobacterium bifidum G9-1 (BBG9-1) could improve the symptoms of diarrhea caused by metformin in animal models. Thus, the primary outcome of this study will be the effect of the probiotic BBG9-1 on gastrointestinal symptoms, including diarrhea, in patients with type 2 diabetes who use metformin. This open-label, single-arm, and exploratory study will examine 40 patients with type 2 diabetes who use metformin and have symptoms of constipation or diarrhea. After the baseline examination (objective 1), patients will be administered probiotic BBG9-1 for 10 ± 2 weeks. Then, examinations will be performed (objective 2). The primary outcome will be changes in the symptoms of constipation or diarrhea from objective 1 to objective 2. Secondary outcomes will include changes in gut microbiota, and correlations between changes in fecal properties and biomarkers, including HbA1c level and body mass index. This is the first study to investigate the effect of probiotic BBG9-1 on the change in the symptom of constipation or diarrhea in patients with type 2 diabetes who use metformin.Metformin is associated with risks of gastrointestinal complications in patients with type 2 diabetes. In contrast, probiotic Bifidobacterium bifidum G9-1 (BBG9-1) could improve the symptoms of diarrhea caused by metformin in animal models. Thus, the primary outcome of this study will be the effect of the probiotic BBG9-1 on gastrointestinal symptoms, including diarrhea, in patients with type 2 diabetes who use metformin. This open-label, single-arm, and exploratory study will examine 40 patients with type 2 diabetes who use metformin and have symptoms of constipation or diarrhea. After the baseline examination (objective 1), patients will be administered probiotic BBG9-1 for 10 ± 2 weeks. Then, examinations will be performed (objective 2). The primary outcome will be changes in the symptoms of constipation or diarrhea from objective 1 to objective 2. Secondary outcomes will include changes in gut microbiota, and correlations between changes in fecal properties and biomarkers, including HbA1c level and body mass index. This is the first study to investigate the effect of probiotic BBG9-1 on the change in the symptom of constipation or diarrhea in patients with type 2 diabetes who use metformin. Metformin is associated with risks of gastrointestinal complications in patients with type 2 diabetes. In contrast, probiotic Bifidobacterium bifidum G9-1 (BBG9-1) could improve the symptoms of diarrhea caused by metformin in animal models. Thus, the primary outcome of this study will be the effect of the probiotic BBG9-1 on gastrointestinal symptoms, including diarrhea, in patients with type 2 diabetes who use metformin. This open-label, single-arm, and exploratory study will examine 40 patients with type 2 diabetes who use metformin and have symptoms of constipation or diarrhea. After the baseline examination (objective 1), patients will be administered probiotic BBG9-1 for 10 ± 2 weeks. Then, examinations will be performed (objective 2). The primary outcome will be changes in the symptoms of constipation or diarrhea from objective 1 to objective 2. Secondary outcomes will include changes in gut microbiota, and correlations between changes in fecal properties and biomarkers, including HbA1c level and body mass index. This is the first study to investigate the effect of probiotic BBG9-1 on the change in the symptom of constipation or diarrhea in patients with type 2 diabetes who use metformin. |
| Author | Nakanishi, Naoko Miyoshi, Tomoki Hata, Shinnosuke Hashimoto, Yoshitaka Hosomi, Yukako Senmaru, Takafumi Ushigome, Emi Yamazaki, Masahiro Fukui, Michiaki Majima, Saori Asano, Mai Osaka, Takafumi Hamaguchi, Masahide Nakajima, Hanako Okada, Hiroshi |
| Author_xml | – sequence: 1 fullname: Hashimoto, Yoshitaka organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 2 fullname: Nakajima, Hanako organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 3 fullname: Hata, Shinnosuke organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 4 fullname: Miyoshi, Tomoki organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 5 fullname: Hosomi, Yukako organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 6 fullname: Majima, Saori organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 7 fullname: Nakanishi, Naoko organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 8 fullname: Senmaru, Takafumi organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 9 fullname: Osaka, Takafumi organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 10 fullname: Okada, Hiroshi organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 11 fullname: Ushigome, Emi organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 12 fullname: Hamaguchi, Masahide organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 13 fullname: Asano, Mai organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 14 fullname: Yamazaki, Masahiro organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine – sequence: 15 fullname: Fukui, Michiaki organization: Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine |
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| References | 10 Blandino G, Inturri R, Lazzara F, Di Rosa M, Malaguarnera L. Impact of gut microbiota on diabetes mellitus. Diabetes Metab 2016; 42: 303–315. 11 Hills RD, Pontefract BA, Mishcon HR, Black CA, Sutton SC, Theberge CR. Gut microbiome: profound implications for diet and disease. Nutrients 2019; 11: 1613. 19 Sumitomo Dainippon Pharma Co., Ltd. METGULCO interview form. https://ds-pharma.jp/product/metglco/attachment/tenpu.html Accessed 26 Feb 2020. 13 Culpepper T, Christman MC, Nieves C Jr, et al. Bifidobacterium bifidum R0071 decreases stress-associated diarrhoea-related symptoms and self-reported stress: a secondary analysis of a randomised trial. Benef Microbes 2016; 7: 327–336. 14 Ibarra A, Latreille-Barbier M, Donazzolo Y, Pelletier X, Ouwehand AC. Effects of 28-day Bifidobacterium animalis subsp. lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms in adults with functional constipation: a double-blind, randomized, placebo-controlled, and dose-ranging trial. Gut Microbes 2018; 9: 236–251. 5 Piper MS, Saad RJ. Diabetes mellitus and the colon. Curr Treat Options Gastroenterol 2017; 15: 460–474. 12 Singh RK, Chang HW, Yan D, et al. Influence of diet on the gut microbiome and implications for human health. J Transl Med 2017; 15: 73. 6 Sanchez-Rangel E, Inzucchi SE. Metformin: clinical use in type 2 diabetes. Diabetologia 2017; 60: 1586–1593. 8 Karlsson FH, Tremaroli V, Nookaew I, et al. Gut metagenome in European women with normal, impaired and diabetic glucose control. Nature 2013; 498: 99–103. 7 Qin J, Li Y, Cai Z, et al. A metagenome-wide association study of gut microbiota in type 2 diabetes. Nature 2012; 490: 55–60. 4 Maisey A. A practical approach to gastrointestinal complications of diabetes. Diabetes Ther 2016; 7: 379–386. 16 Makizaki Y, Maeda A, Yamamoto M, et al. Bifidobacterium bifidum G9-1 ameliorates soft feces induced by metformin without affecting its antihyperglycemic action. Biosci Microbiota Food Health 2020. DOI: 10.12938/bmfh.2019-022 17 Kalman DS, Schwartz HI, Alvarez P, Feldman S, Pezzullo JC, Krieger DR. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms. BMC Gastroenterol 2009; 9: 85. 2 Zawada AE, Moszak M, Skrzypczak D, Grzymisławski M. Gastrointestinal complications in patients with diabetes mellitus. Adv Clin Exp Med 2018; 27: 567–572. 3 Bytzer P, Talley NJ, Leemon M, Young LJ, Jones MP, Horowitz M. Prevalence of gastrointestinal symptoms associated with diabetes mellitus: a population-based survey of 15,000 adults. Arch Intern Med 2001; 161: 1989–1996. 18 Francavilla R, Piccolo M, Francavilla A, et al. Clinical and microbiological effect of a multispecies probiotic supplementation in celiac patients with persistent IBS-type symptoms: a randomized, double-blind, placebo-controlled, multicenter trial. J Clin Gastroenterol 2019; 53: e117–e125. 9 Brunkwall L, Orho-Melander M. The gut microbiome as a target for prevention and treatment of hyperglycaemia in type 2 diabetes: from current human evidence to future possibilities. Diabetologia 2017; 60: 943–951. 15 Agrawal A, Houghton LA, Morris J, et al. Clinical trial: the effects of a fermented milk product containing Bifidobacterium lactis DN-173 010 on abdominal distension and gastrointestinal transit in irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2009; 29: 104–114. 1 Chatterjee S, Khunti K, Davies MJ. Type 2 diabetes. Lancet 2017; 389: 2239–2251. 11 12 13 14 15 16 17 18 19 1 2 3 4 5 6 7 8 9 10 |
| References_xml | – reference: 15 Agrawal A, Houghton LA, Morris J, et al. Clinical trial: the effects of a fermented milk product containing Bifidobacterium lactis DN-173 010 on abdominal distension and gastrointestinal transit in irritable bowel syndrome with constipation. Aliment Pharmacol Ther 2009; 29: 104–114. – reference: 11 Hills RD, Pontefract BA, Mishcon HR, Black CA, Sutton SC, Theberge CR. Gut microbiome: profound implications for diet and disease. Nutrients 2019; 11: 1613. – reference: 13 Culpepper T, Christman MC, Nieves C Jr, et al. Bifidobacterium bifidum R0071 decreases stress-associated diarrhoea-related symptoms and self-reported stress: a secondary analysis of a randomised trial. Benef Microbes 2016; 7: 327–336. – reference: 4 Maisey A. A practical approach to gastrointestinal complications of diabetes. Diabetes Ther 2016; 7: 379–386. – reference: 9 Brunkwall L, Orho-Melander M. The gut microbiome as a target for prevention and treatment of hyperglycaemia in type 2 diabetes: from current human evidence to future possibilities. Diabetologia 2017; 60: 943–951. – reference: 19 Sumitomo Dainippon Pharma Co., Ltd. METGULCO interview form. https://ds-pharma.jp/product/metglco/attachment/tenpu.html Accessed 26 Feb 2020. – reference: 5 Piper MS, Saad RJ. Diabetes mellitus and the colon. Curr Treat Options Gastroenterol 2017; 15: 460–474. – reference: 17 Kalman DS, Schwartz HI, Alvarez P, Feldman S, Pezzullo JC, Krieger DR. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms. BMC Gastroenterol 2009; 9: 85. – reference: 3 Bytzer P, Talley NJ, Leemon M, Young LJ, Jones MP, Horowitz M. Prevalence of gastrointestinal symptoms associated with diabetes mellitus: a population-based survey of 15,000 adults. Arch Intern Med 2001; 161: 1989–1996. – reference: 10 Blandino G, Inturri R, Lazzara F, Di Rosa M, Malaguarnera L. Impact of gut microbiota on diabetes mellitus. Diabetes Metab 2016; 42: 303–315. – reference: 8 Karlsson FH, Tremaroli V, Nookaew I, et al. Gut metagenome in European women with normal, impaired and diabetic glucose control. Nature 2013; 498: 99–103. – reference: 16 Makizaki Y, Maeda A, Yamamoto M, et al. Bifidobacterium bifidum G9-1 ameliorates soft feces induced by metformin without affecting its antihyperglycemic action. Biosci Microbiota Food Health 2020. DOI: 10.12938/bmfh.2019-022 – reference: 1 Chatterjee S, Khunti K, Davies MJ. Type 2 diabetes. Lancet 2017; 389: 2239–2251. – reference: 18 Francavilla R, Piccolo M, Francavilla A, et al. Clinical and microbiological effect of a multispecies probiotic supplementation in celiac patients with persistent IBS-type symptoms: a randomized, double-blind, placebo-controlled, multicenter trial. J Clin Gastroenterol 2019; 53: e117–e125. – reference: 6 Sanchez-Rangel E, Inzucchi SE. Metformin: clinical use in type 2 diabetes. Diabetologia 2017; 60: 1586–1593. – reference: 7 Qin J, Li Y, Cai Z, et al. A metagenome-wide association study of gut microbiota in type 2 diabetes. Nature 2012; 490: 55–60. – reference: 12 Singh RK, Chang HW, Yan D, et al. Influence of diet on the gut microbiome and implications for human health. J Transl Med 2017; 15: 73. – reference: 14 Ibarra A, Latreille-Barbier M, Donazzolo Y, Pelletier X, Ouwehand AC. Effects of 28-day Bifidobacterium animalis subsp. lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms in adults with functional constipation: a double-blind, randomized, placebo-controlled, and dose-ranging trial. Gut Microbes 2018; 9: 236–251. – reference: 2 Zawada AE, Moszak M, Skrzypczak D, Grzymisławski M. Gastrointestinal complications in patients with diabetes mellitus. Adv Clin Exp Med 2018; 27: 567–572. – ident: 9 doi: 10.1007/s00125-017-4278-3 – ident: 15 doi: 10.1111/j.1365-2036.2008.03853.x – ident: 18 doi: 10.1097/MCG.0000000000001023 – ident: 2 doi: 10.17219/acem/67961 – ident: 11 doi: 10.3390/nu11071613 – ident: 13 doi: 10.3920/BM2015.0156 – ident: 19 – ident: 7 doi: 10.1038/nature11450 – ident: 16 doi: 10.12938/bmfh.2019-022 – ident: 17 doi: 10.1186/1471-230X-9-85 – ident: 3 doi: 10.1001/archinte.161.16.1989 – ident: 1 doi: 10.1016/S0140-6736(17)30058-2 – ident: 5 doi: 10.1007/s11938-017-0151-1 – ident: 14 doi: 10.1080/19490976.2017.1412908 – ident: 10 doi: 10.1016/j.diabet.2016.04.004 – ident: 4 doi: 10.1007/s13300-016-0182-y – ident: 6 doi: 10.1007/s00125-017-4336-x – ident: 12 doi: 10.1186/s12967-017-1175-y – ident: 8 doi: 10.1038/nature12198 |
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| Snippet | Metformin is associated with risks of gastrointestinal complications in patients with type 2 diabetes. In contrast, probiotic Bifidobacterium bifidum G9-1... Metformin is associated with risks of gastrointestinal complications in patients with type 2 diabetes. In contrast, probiotic Bifidobacterium bifidum G9-1... |
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| SubjectTerms | Animal models Antidiabetics Bifidobacterium bifidum biguanides Biomarkers Body mass index Body size Constipation Diabetes Diabetes mellitus Diabetes mellitus (non-insulin dependent) Diarrhea gastrointestinal complications Gastrointestinal symptoms gut microbiota Intestinal microflora Metformin Microbiota Probiotics Protocol type 2 diabetes |
| Title | Effect of probiotics, Bifidobacterium bifidum G9-1, on gastrointestinal symptoms in patients with type 2 diabetes mellitus: study protocol for open-label, single-arm, exploratory research trial (Big STAR study) |
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