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Metformin with Versus without Concomitant Probiotic Therapy in Newly Diagnosed Patients with Type 2 Diabetes or Prediabetes: A Comparative Analysis in Relation to Glycemic Control, Gastrointestinal Side Effects, and Treatment Compliance.

  • 2022-11-15
  • The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology 33(11)
    • Kübra Şahin
    • Yasin Şahintürk
    • Gökhan Köker
    • Gülhan Özçelik Köker
    • Feyzi Bostan
    • Mehmet Kök
    • Seyit Uyar
    • Ayhan Hilmi Çekin

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 156
Population
156 patients (mean [standard deviation] age: 50.9 [9.9 years], 74.4% females) with newly diagnosed type 2 diabetes or prediabetes
Methods
randomly assigned to receive either metformin alone (n = 84, MET group) or metformin plus Bifidobacterium animalis subsp. lactis (BB-12) probiotic (n = 72, MET-PRO group)
Duration
3 months
Funding
Unclear
  • Large Human Trial

Background

To evaluate the impact of concomitant use of probiotic BB-12 in metformin-treated patients with type 2 diabetes or prediabetes on glycemic control, metformin-related gastrointestinal side effects, and treatment compliance.

Methods

A total of 156 patients (mean [standard deviation] age: 50.9 [9.9 years], 74.4% females) with newly diagnosed type 2 diabetes or prediabetes were randomly assigned to receive either metformin alone (n = 84, MET group) or metformin plus Bifidobacterium animalis subsp. lactis (BB-12) probiotic (n = 72, MET-PRO group). Data on body mass index (kg/m2), fasting blood glucose (mg/dL), blood lipids, and glycated hemoglobin (HbA1c) levels were recorded at baseline and at the third month of therapy. Data on gastrointestinal intolerance symptoms and treatment noncompliance were also recorded during post-treatment week 1 to week 4.

Results

MET-PRO versus MET therapy was associated with a significantly higher rate of treatment compliance (91.7% vs 71.4%, P = .001), greater reduction from baseline HbA1c values (0.9 [0.4-1.6] vs 0.4 [0-1.6] %, P < .001) and lower likelihood of gastrointestinal intolerance symptoms, including abdominal pain (P = .031 to <.001), diarrhea (P = .005 to <.001) and bloating (P = .010 to <.001). Noncompliance developed later (at least 15 days after the therapy) in a significantly higher percentage of patients in the MET group (P = .001 for 15-21 days and P = .002 for 22-28 days).

Conclusion

In conclusion, the present study proposes the benefit of combining probiotics with metformin in the treatment of patients with T2D or prediabetes in terms of improved glycemic control and treatment adherence rather than correction of dyslipidemia or weight reduction.

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