Endocrine Abstracts

Background: Probiotics have beneficial effect on obesity/type 2 diabetes (T2D) related disorders in both animal models and clinical trials, at the same time, some scientific papers question the effectiveness and the safety of probiotics. In turn, postbiotics are preparations of inanimate microorganisms and / or their components, which are directly identified with the safety of their use and the health benefits of the host.

Aim: To conduct placebo-controlled randomize clinical trial (RCT) to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on glycemic control parameters, insulin resistance, β-cells functional activity and anthropometric parameters in T2D patients.

Method: A total of 55 patients met the criteria for inclusion. The study includes 3 periods. Screening period of up to 1 week to assess the eligibility to inclusion/exclusion criteria. Treatment and follow-up periods for 3 months each. The participants receive a twice daily oral dose of postbiotics « Del-Immune V® Extra» (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV-NRRLB-68023) at the assigned dose of 100 mg or placebo in capsules. The primary main outcomes were the change of HbA1c and fasting plasma glucose (FPG). Secondary outcomes were the changes in HOMA-IR, insulin sensitivity (%S) and β-cells functional activity (%B) as assessed by HOMA-2 model and anthropomorphic variables. Trial registration: NCT05770076.

Results: Supplementation with postbiotic for 3 month was associated with significant reduction of HbA1c (7.88±1.07 to 7.25±0.92%; P=0.001) and FPG (7.99±3.89 to 6.67±2.01 mmol/l; P=0.030) mainly due to improvement of β-cells functional activity (%B-78.77±41.26 to 91.17±38.99; P=0.011). Also in postbiotic group insignificant improvement of insulin sensitivity was found (%S-60.69±26.09 to 64.45±28.04; P=0.235). In placebo group significant worsening of glycemic conrol in intra-group analysis was observed: HbA1C and FPG decreased on 6.85% (P=0.05) and 1.6% (P=0.696) respectively as compared to baseline value. In both groups we observed the reduction of anthropometric parameters. However, only in postbiotic group it was significant. After intervention discontinuation, at follow up visit worsening of endpoints was found as compared to end of treatment visit However, parameters did not achieve the baseline level.

Conclusion: To our knowledge its first RCT which demonstrate that postbiotic supplementation can improve glycemic-related parameters and β-cells functional activity in patients with T2D. Modulation of the gut microbiota represents a new treatment for T2D/obesity and should be tested in larger studies.