At a glance
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Effect of Probiotic Lysate (Postbiotic and Metabiotic) Supplementation on Metabolic Parameters in Type 2 Diabetes Patients
In Brief
A clinical study evaluating Probiotic lysate (postbiotic and metabiotic) and Placebo for Obesity and 5 related conditions. Completed, enrolled 55 participants across 4 sites.
Detailed Summary
The current study aim was to conduct placebo-controlled randomize clinical trial to assess the short-term efficacy and safety of postbiotics as an adjunction to the standard anti-diabetic therapy on insulin resistance, glycemic control parameters, β-cells functional activity, anthropometric parameters and markers of a chronic systemic inflammatory response in type 2 diabetes patients. The study will include 3 periods. Screening period of up to 1 weeks to assess the eligibility to inclusion/exclusion criteria. Treatment period for 3 month where the participants will receive a twice daily oral dose of postbiotics (cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023) at the assigned dose of 100mg or placebo in capsules. During this period monthly phone contacts will be done for assessment of compliance and safety concerns. Follow-up period of up to 3 month.
Study Details
Timeline
Interventions
Each capsule contains 100 mg of cell lysate and DNA fragments of the probiotic strain L. rhamnosus DV - NRRLB-68023 in powder
Placebo