Pilot, double-blind, randomized, placebocontrolled clinical trial of the supplement food Nyaditum resae® in adults with or without latent TB infection: Safety and immunogenicity
Montané Esteva, Eva (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Barriocanal, Ana María (Universitat Autònoma de Barcelona. Departament de Farmacologia, de Terapèutica i de Toxicologia)
Arellano, Ana Lucía (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Valderrama, Angelica (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Sanz, Yolanda (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Pérez-Álvarez, Núria (Institut Germans Trias i Pujol. Fundació de Lluita Contra la Sida)
Cardona, Paula (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Vilaplana, Cristina (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)
Cardona, Pere-Joan (Institut Germans Trias i Pujol. Hospital Universitari Germans Trias i Pujol)

Data:	2017
Resum:	Background. Nyaditum resae® (NR) is a galenic preparation of heat-killed Mycobacterium manresensis, a new species of the fortuitum complex, that is found in drinkable water, and that has demonstrated to protect against the development of active TB in a murine experimental model that develop human-like lesions. Methods. Double-blind, randomized, placebo-controlled Clinical Trial (51 volunteers included). Two different doses of NR and a placebo were tested, the randomization was stratified by Latent Tuberculosis Infection (LTBI)-positive (n = 21) and LTBI-negative subjects (n = 30). Each subject received 14 drinkable daily doses for 2 weeks. Results. All patients completed the study. The 46. 3% of the overall reported adverse events (AE) were considered related to the investigational treatment. None of them were severe (94% were mild and 6% moderate). No statistical differences were found when comparing the median number of AE between the placebo group and both treatment groups. The most common AE reported were gastrointestinal events, most frequently mild abdominal pain and increase in stool frequency. Regarding the immunogenic response, both LTBI-negative and LTBI-positive volunteers treated with NR experienced a global increase on the Treg response, showed both in the population of CD25+CD39-, mainly effector Treg cells, or CD25+CD39+ memory PPD-specific Treg cells. Conclusion. This clinical trial demonstrates an excellent tolerability profile of NR linked to a significant increase in the population of specific effector and memory Tregs in the groups treated with NR in both LTBI-positive and negative subjects. NR shows a promising profile to be used to reduce the risk of active TB.
Ajuts:	European Commission FEDER/CP13/00174 European Commission FEDER/IFI14/00015
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	PloS one, february 2017, p. 1-20, ISSN 1932-6203

DOI: 10.1371/journal.pone.0171294
PMID: 28182700

20 p, 3.0 MB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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