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; р=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.