Effects of probiotic Bifidobacterium bifidum G9‐1 on the gastrointestinal symptoms of patients with type 2 diabetes mellitus treated with metformin: An open‐label, single‐arm, exploratory research trial

Abstract

Aims/Introduction: Metformin is associated with the risk of gastrointestinal complications, and probiotic Bifidobacterium bifidum G9-1 (BBG9-1) can improve the symptoms of diarrhea. This study aimed to clarify the effects of probiotic BBG9-1 on the gastrointestinal symptoms of type 2 diabetes mellitus patients using metformin. Materials and methods:In this open-label single-arm exploratory study, 40 patients (mean age 64.0 -9.4 years) were given probiotic BBG9-1 for 10 weeks. Changes in the gastrointestinal symptom rating scale total score, which was the primary end-point, gastrointestinal symptom rating scale subscale scores, glycated hemoglobin levels and gut microbiota after the administration of probiotic BBG9-1 were evaluated by the Student's t-test. Results: The gastrointestinal symptom rating scale total score significantly improved (from 2.02 -0.51 to 1.59 -0.43, change, -0.43 -0.49, P < 0.001). Furthermore, all gastrointestinal symptom rating scale subscale scores, including diarrhea (from 2.32 -1.14 to 1.89 -0.99, change, -0.42 -0.95, P = 0.007) and constipation (from 3.00 -1.16 to 2.20 -1.07, change, -0.80 -1.19, P < 0.001), scores also significantly improved. However, the glycated hemoglobin levels did not change (from 7.0 -0.7 to 7.0 -0.6%, change, 0.0 -0.4, P = 0.91). The relative abundance of the genus Sutterella decreased by the use of probiotic BBG9-1 (from 0.011 -0.009 to 0.008 -0.006, change, -0.003 -0.006, P = 0.002). Conclusions: Type 2 diabetes mellitus patients treated with metformin showed significant improvement in all gastrointestinal symptom rating scores after using probiotic BBG9-1 without changing the glucose control. This study showed the potential usefulness of probiotic BBG9-1 for improving gastrointestinal symptoms, including constipation and diarrhea, in type 2 diabetes mellitus patients treated with metformin.

Pediococcus acidilactici pA1c® Improves the Beneficial Effects of Metformin Treatment in Type 2 Diabetes by Controlling Glycaemia and Modulating Intestinal Microbiota

“…In this respect, a previous study suggested that gastrointestinal symptoms with metformin use could be due to the enrichment in Escherichia species [57]; thus, microbiotatargeted interventions such as probiotics could help to recover a healthy microbiota and re-establish gut homeostasis. Indeed, a previous study confirmed that the combination of metformin and the probiotic Bifidobacterium bifidum G9-1 (BBG9-1) resulted in improved gastrointestinal symptoms (diarrhea and constipation scores) in subjects with T2D [58]. Given all the above, and in agreement with the results reported in this study, it seems that the simultaneous administration of probiotic strains and metformin would provide more benefits than the single treatments.…”

“…Other studies carried out on probiotics and the combination with metformin have been described in the literature, both in murine models [28,99] and in humans [58,100,101] in the context of T2D. In the same line, other studies tested this combination in different clinical contexts, such as ulcerative colitis [55], colorectal cancer [56], non-alcoholic steatohepati-tis [102] and polycystic ovarian syndrome [103].…”

The Probiotic Lactobacillus paracasei Ameliorates Diarrhea Cause by Escherichia coli O8via Gut Microbiota Modulation1

“…Bifidobacterium lactis Probio -M8 prevented and treated acute respiratory tract infections and shortened the duration of nasal, pharyngeal, and flu-like symptoms ( 42 ). Bifidobacterium bifidum G9-1 improved gastrointestinal symptoms in type 2 diabetes mellitus (T2DM) ( 43 ). Lab4 supplementation effectively prevented certain cardiovascular diseases ( 44 ).…”

Protocol of efficacy of bifidobacteria intake on gastrointestinal symptoms in symptomatic type 2 diabetes mellitus patients in abdominis: An open-label, randomized controlled trial (Binary STAR study)

“…In a sub-analysis of a previous study [ 15 , 18 ], BBG9-1 oral administration changed the total GSRS score by -0.441 ± 0.499. In the non-treatment period, the change in the total GSRS score was -0.197 ± 0.314.…”

“…In addition, we recently revealed that the probiotic Bifidobacterium bifidum G9-1 (BBG9-1) improved the symptoms of constipation and diarrhea in patients with T2DM [ 15 ]. However, the study was an open-label, single-arm exploratory study [ 15 ], and further research is needed to determine its effectiveness and mechanism. Therefore, this randomized, parallel-group study will investigate the efficacy of the probiotic BBG9-1 on the symptoms of diarrhea or constipation in patients with T2DM.…”