Efficacy of probiotics (Bifidobacterium bifidum G9-1) in patients with type 2 diabetes mellitus and chronic kidney disease complicated by constipation: An exploratory, multicenter, open-label, single-arm study (BIRDIE study).

The proportion of patients with normal stool form significantly increased from baseline to week 12 following Bifidobacterium bifidum G9-1 administration.

• Normal stool form was defined as Bristol Scale score ≥3.5 to <4.5.
• At baseline, 3.3% (1 patient) had normal stool form.
• At week 12, 44.8% (13 patients) had normal stool form.
• The increase was statistically significant (P = 0.002).
• The study enrolled 30 patients with type 2 diabetes mellitus and chronic kidney disease complicated by constipation.

The median Bristol Stool Scale score significantly increased from baseline at both week 6 and week 12.

• The median Bristol score increased by 0.6 from baseline to week 6 (P < 0.001).
• The median Bristol score increased by 0.5 from baseline to week 12 (P < 0.001).
• Both timepoints showed statistically significant improvements.

Defecation frequency significantly increased from baseline to week 6 following Bifidobacterium bifidum G9-1 treatment.

• Defecation frequency increased by 0.2 ± 0.4 from baseline to week 6.
• The increase was statistically significant (P = 0.026).
• This was assessed as a secondary endpoint of the study.

Gastrointestinal symptom scores on the Gastrointestinal Symptom Rating Scale significantly decreased following treatment.

• Total constipation, abdominal pain, and indigestion scores on the Gastrointestinal Symptom Rating Scale all significantly decreased.
• Abdominal symptoms including straining, feelings of incomplete evacuation, bloating, and discomfort also significantly decreased.
• These outcomes were measured as part of quality of life secondary endpoints.

Glycated hemoglobin and estimated glomerular filtration rate did not change significantly, while urinary albumin levels significantly decreased at week 6.

• Glycated hemoglobin did not change significantly over the 12-week treatment period.
• Estimated glomerular filtration rate did not change significantly over the 12-week treatment period.
• Urinary albumin levels significantly decreased at week 6.
• These findings indicate that Bifidobacterium bifidum G9-1 did not worsen glycemic control or renal function.

This was a multicenter, open-label, single-arm exploratory trial administering Bifidobacterium bifidum G9-1 for 12 weeks to patients with type 2 diabetes mellitus and chronic kidney disease complicated by constipation.

• The study enrolled 30 patients.
• The treatment duration was 12 weeks.
• The primary endpoint was the proportion of patients with normal stool form (Bristol Scale score ≥3.5 to <4.5).
• Secondary endpoints included stool form, defecation frequency, and quality of life.
• The study design was multicenter and open-label with a single arm (no control group).