The results of the first Clinical Trial of Nyaditum resae®, released

IMG_4534The Experimental Tuberculosis Unit, together with the Pharmacology Dept of the Hospital Universitari Germans Trias i Pujol and the Clinical Trials’ Unit of the IGTP, present today the results of NYADATREG (ClinicalTrials.gov Identifier: NCT02076139) , the first clinical trial conducted with the food supplement Nyaditum resae®. Designed and patented at the Experimental tuberculosis Unit and fully transferred to the spin-off Manremyc (created for continue its development), Nyaditum resae®  is a nutraceutical with natural origin, a low-cost production, well-tolerated and safe; a new tool to reduce the risk of developing active tuberculosis.

The results of this CT  have been presented at the World Conference on Tuberculosis and Lung Health organized by the Union and held in Barcelona (28th Oct-1st Nov), showing a good safety profile and its capacity as immunomodulator. The tolerability of the food supplement  Nyaditum resae®  was excellent. The Adverse Effects recorded were mostly gastrointestinals and mild, and no statistically significant differences were found between the treated groups with Nyaditum resae® and the Placebo group. The analysis of the immunogenicity showed a significant increase in the population of specific effector and memory Tregs in the groups treated with Nyaditum resae® in both PPD positive & negative subjects. It has been experimentally demonstrated that these cells are the responsable for balancing the excessive inflammatory response that led to the induction of active TB.

You can Access the pdf of the results, here.

 

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