Effect of oral administration of probiotic preparation VSL#3, a clinically safe mixture of 8 strains of viable live, lyophilized lactic acid bacteria, on the metabolic control in individuals with type-1 diabetes mellitus (T1DM); a randomized, double-blind, placebo controlled trial – A pilot study

Proposed study is a randomized, double-blind, placebo controlled pilot study to check for effect of oral administration of probiotic preparation VSL#3, a clinically safe mixture of 8 strains of viable live, lyophilized lactic acid bacteria, on the metabolic control in individuals with type-1 diabetes mellitus (T1DM). Type 1 diabetes mellitus is an autoimmune disease that develops in genetically predisposed individuals. Probiotics are nonpathogenic live microorganisms that, when ingested, confer health benefits to the host. Probiotics also have been shown to support the maturity of the gut immune system and could therefore support oral tolerance and protection against enteral virus infections, that is, risk factors of T1DM. A potential role for probiotics in altering the natural history of autoimmune diabetes has been suggested by a recent study. Ina study by Calcinaro et al, the authors concluded that orally administered VSL#3 prevents autoimmune diabetes and induces immunomodulation by a reduction in insulitis severity. This study is designed to see whether probiotics by virtue of their anti-inflammatory action, can inhibit ongoing beta cell destruction in already established type-1 diabetic individuals and thereby improve glycemic control.xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /