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

  • 2026-04-22
  • Diabetes, obesity & metabolism 28(7)
    • Genki Kobayashi
    • Yoshitaka Hashimoto
    • Tomoyuki Matsuyama
    • Noriyuki Kitagawa
    • Saori Majima
    • Takafumi Senmaru
    • Emi Ushigome
    • Hiroshi Okada
    • Naoko Nakanishi
    • Masahide Hamaguchi
    • Michiaki Fukui

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 100
Population
100 patients with Type 2 diabetes mellitus with diarrhoea or constipation
Methods
12-week open-label randomised controlled trial, 100 participants randomized 1:1 to control or BBG9-1 group, with 12 mg of Bifidobacterium administered daily
Blinding
Open-label
Duration
12 weeks
Funding
Unclear
  • Large Human Trial

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/m2. 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).

Research Insights

Adverse Events Reported

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