Development of the food supplement Nyaditum resae as a new tool to reduce the risk of tuberculosis development

Publication date: Available online 14 November 2016 Source:International Journal of Mycobacteriology Author(s): Nestani Tukvadze, Paula Cardona, Sergo Vashakidze, Natalia Shubladze, Zaza Avaliani, Cris Vilaplana, Pere-Joan Cardona Nyaditum resae (NR) is a galenic preparation of heat-killed Mycobacterium manresensis (hkMn). This is a new species that belongs to the Mycobacterium fortuitum complex, and it is present in drinking water—thus, regulatorily speaking, it is considered a food supplement. Preclinical studies in the murine model of active tuberculosis (TB) in the C3HeB/FeJ strain have demonstrated that daily administration of NR containing 103–106 hkMn for 14days was able to stop the progression toward active TB [1]. The mechanism of action was linked to the induction of low dose tolerance and was related to the increase of PPD memory-specific Tregs (CD4+CD25+CD39+ cells) after ex vivo incubation of splenocytes for 7days. This increase of Tregs was related to the increase of interleukin (IL)-10 in the spleen and in the reduction of IL-17 in the lungs, where there was also a reduction in bacillary load and the pathology caused by a reduction of neutrophiles’ infiltration [2]. Two randomized, double-blind placebo-controlled clinical trials (CTs) have been conducted in humans. The NYADATREG study (Clinicaltrials.gov identifier NCT02076139; 2013–2014) was aimed to evaluate the safety and the immunogenicity of two concentrations of NR (containing 104 hkMn an...
Source: International Journal of Mycobacteriology - Category: Infectious Diseases Source Type: research