Metabolic Benefits of Probiotic Combination with Absorbent Smectite in type 2 Diabetes Patients a Randomised Controlled Trial

Background: Numerous non-drug therapies have emerged in recent years for the prevention and improvement of type 2 diabetes (T2D). However, therapies based on dietary modification and/or microbiota may replace a large part of drug therapies in the coming years. Aim: The aim of the current study was to conduct placebo-controlled randomize clinical trial for the efficiency of a combination of multiprobiotics with smectite absorbent gel (Symbiter-Forte formulation) as an adjunction to the standard anti-diabetic therapy. Methods: A total of 55 patients met the criteria and were included in double-blind single center RCT, to receive “Symbiter-Smectite” or placebo for 8-weeks administered as a sachet formulation. The primary outcome was the change in HOMA2-IR and insulin sensitivity (% S). Secondary outcomes were glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response. Results: Combined use of the probiotic mixture with smectite leads to a significant reduction in HOMA2-IR (3.14±0.97 vs 2.79±0.85; #128;=0.009) and improvement in % S (34.65±9.92 vs 39.42±12.78; p=0.011) after 8 weeks of the treatment period. Simultaneously, in the secondary outcome analysis lowering of HbA1c, waist circumference but not BMI and pro-inflammatory cytokines IL-1β (p=0.004), TNF-α (p=0.008), IL-6 (p=0.005) and IL-8 (p=0.042) were detected. In placebo group, changes were insignificant. Conclusion: Probiotic with smectite due to its absorbent activity and stabilization mucus layer properties can impact the synergistic enhancement of a single effect, which manifested with a significant reduction in IR, waist circumference, markers of chronic systemic inflammation and improvement of glycemic profile as compared to placebo.