Bifidobacterium bifidum G9‐1 Intake Improves Gastrointestinal Symptoms in Type 2 Diabetes Mellitus: An Open‐Label, Randomized Controlled Trial (Binary STAR Study)
Primary result · GSRS total scoreResult — go to the resultBetween-group difference −0.34 95% CI −0.55 to −0.14Authors' conclusion
BBG9-1 administration significantly improved gastrointestinal symptoms in patients with T2DM.
Study context
- Population
- Patients with T2D with diarrhoea or constipationrandomized 1:1
- Participants
- 100 patients
- Comparison
- Bifidobacterium bifidum G9-1 vs control
- BBG9-1n = 43
- Controln = 51reference
- Primary endpoint
- Change in total Gastrointestinal Symptom Rating Scale (GSRS) score (range: 1-7), full analysis set
- Follow-up
- 12 weeks
Methodological detailsopen-label
- Open-label
Primary result
GSRS total score
Between-group difference
−0.34
95% CI −0.55 to −0.14
P = 0.001
By group
BBG9-1
1.83
SD 0.62
Control
2.06
SD 0.63
BBG9-1vs Control
between-group difference −0.34 (95% CI −0.55 to −0.14); P = 0.001
As reported in the abstract
Further findings
| Outcome | BBG9-1 | Control | P value |
|---|---|---|---|
| GSRS constipation score, mean change | −0.79 (SD 1.38) | −0.13 (SD 1.04) | P = 0.013 |
| GSRS diarrhoea score, mean change | −0.42 (SD 1.14) | −0.06 (SD 1.08) | P = 0.14 |
| GSRS diarrhoea score at follow-up | 2.04 (SD 1.00) | 2.58 (SD 1.44) | P = 0.049 |
| Relative abundance of genus Phocaeicola | 19.56% (SD 14.79%) | 18.21 (SD 13.58) | P = 0.042 |
| Baseline | 15.98 ± 13.75 | 18.14 ± 14.17 |
Gastrointestinal Symptom Rating Scale (GSRS) total score improvement by subgroup
- Greater GSRS total score improvement in women, participants with constipation, aged ≥ 65 years, and BMI < 25 kg/m²
Faecal short-chain fatty acids (SCFAs)
- No significant changes associated with BBG9-1 administration
Safety
- Incidence of adverse effects similar between the groups
Original publication
Bifidobacterium bifidum G9‐1 Intake Improves Gastrointestinal Symptoms in Type 2 Diabetes Mellitus: An Open‐Label, Randomized Controlled Trial (Binary STAR Study). Diabetes Obes Metab. Published 22 April 2026. doi:10.
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