Bifidobacterium bifidum G9‐1 Intake Improves Gastrointestinal Symptoms in Type 2 Diabetes Mellitus: An Open‐Label, Randomized Controlled Trial (Binary STAR Study)

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Abstract
Aims: To evaluate the effects of probiotics Bifidobacterium bifidum G9‐1 (BBG9‐1) on gastrointestinal symptoms in patients with Type 2 diabetes mellitus (T2DM) with diarrhoea or constipation. Materials and Methods: In a 12‐week open‐label randomised controlled trial, 100 participants were randomized 1:1 to a control or BBG9‐1 group, with 12 mg of Bifidobacterium administered daily. The primary endpoint was the change in total Gastrointestinal Symptom Rating Scale (GSRS) score (range: 1–7) in the full analysis set (BBG9‐1: n = 43; control: n = 51). Results: BBG9‐1 intake significantly improved the 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; between‐group difference, −0.34 [95% CI: −0.55 to −0.14; p = 0.001]). Subgroup analyses indicated greater GSRS total score improvement in women, participants with constipation, aged ≥ 65 years, and BMI < 25 kg/m 2 . Among the GSRS subscales, BBG9‐1 showed a significantly greater mean reduction in constipation scores than control (−0.79 ± 1.38 vs. −0.13 ± 1.04; p = 0.013). Although the mean change in diarrhoea scores did not differ significantly (−0.42 ± 1.14 vs. −0.06 ± 1.08; p = 0.14), the follow‐up diarrhoea score was significantly lower with BBG9‐1 (2.04 ± 1.00 vs. 2.58 ± 1.44; p = 0.049). Through gut microbiota analysis, the relative abundance of genera Phocaeicola increased significantly in the 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). Assessment of faecal short‐chain fatty acids (SCFAs) revealed no significant changes associated with BBG9‐1 administration. The incidence of adverse effects were similar between the groups. Conclusions: BBG9‐1 administration significantly improved gastrointestinal symptoms in patients with T2DM. Trial Registration: Japan Registry of Clinical Trials (jRCTs051220127)

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