1797-P: Efficacy of Bifidobacteria Intake on Gastrointestinal Symptoms in Symptomatic Type 2 Diabetes Mellitus Patients in Abdominis: Open-Label, Randomized, Controlled Trial (Binary STAR Study)

Introduction and Objective: In addition to micro- and macrovascular complications, gastrointestinal diseases have been reported to be associated with diabetes. To evaluate the effect of probiotic Bifidobacterium bifidum G9-1 (BBG9-1) on gastrointestinal symptoms in people with type 2 diabetes (T2D) suffering from diarrhea or constipation. Methods: In this open-label, 12-week, randomized-controlled trial, 100 people were randomly assigned 1:1 to either the BBG9-1 group or control group. Primary endpoint is the change in gastrointestinal symptom rating scale (GSRS) total score in full set group. Results: Of the 49 participants in the BBG9-1 group and 51 in the control group, 43 (62.8±8.8 years, 26.5±7.6 kg/m², 26 men) and all 51 (62.0±9.4 years, 26.4±4.4 kg/m², 32 men) completed the test, respectively. BBG9-1 intake significantly improved GSRS total score (from 2.22±0.67 to 1.83±0.62) compared with control (from 2.08±0.67 to 2.06±0.63), with a between-group difference of -0.34 (95% CI: -0.55 to -0.14; p = 0.001). Among the GSRS subscale, diarrhea scores in the BBG9-1 group (from 2.49±1.25 to 2.04±1.00) tended to be improved compared with the control group (from 2.62±1.46 to 2.58±1.44, p= 0.14), while constipation scores improved significantly in the BBG9-1 group (from 3.02±1.34 to 2.28±1.21) compared with the control group (from 2.75±1.44 to 2.63±1.25, p= 0.013). In addition, through gut microbiota analysis, relative abundance of genera Phocaeicola, which was associated with short-chain fatty acid production, increased significantly in BBG9-1 group (from 15.98±13.75 to 19.56±14.79 % vs. from 18.14±14.17 to 18.21±13.58, p = 0.042), There were no serious adverse effects were observed in either group and no significant difference in the incidence of adverse effects between the groups. Conclusion: BBG9-1 intake significantly improved gastrointestinal symptoms in people with T2D. Disclosure Y. Hashimoto: None. H. Okada: None. M. Fukui: None. M. Hamaguchi: Research Support; Current; AstraZeneca, Kowa Company, Ltd. G. Kobayashi: None. Funding Biofermin Pharmaceutical Co., Ltd.