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Pilot, double-blind, randomized, placebo-controlled clinical trial of the supplement food Nyaditum resae(®) in adults with or without latent TB infection: Safety and immunogenicity
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-...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5300153/ https://www.ncbi.nlm.nih.gov/pubmed/28182700 http://dx.doi.org/10.1371/journal.pone.0171294 |
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author | Montané, Eva Barriocanal, Ana Maria Arellano, Ana Lucía Valderrama, Angelica Sanz, Yolanda Perez-Alvarez, Nuria Cardona, Paula Vilaplana, Cristina Cardona, Pere-Joan |
author_facet | Montané, Eva Barriocanal, Ana Maria Arellano, Ana Lucía Valderrama, Angelica Sanz, Yolanda Perez-Alvarez, Nuria Cardona, Paula Vilaplana, Cristina Cardona, Pere-Joan |
author_sort | Montané, Eva |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5300153 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-53001532017-02-28 Pilot, double-blind, randomized, placebo-controlled clinical trial of the supplement food Nyaditum resae(®) in adults with or without latent TB infection: Safety and immunogenicity Montané, Eva Barriocanal, Ana Maria Arellano, Ana Lucía Valderrama, Angelica Sanz, Yolanda Perez-Alvarez, Nuria Cardona, Paula Vilaplana, Cristina Cardona, Pere-Joan PLoS One Research Article 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. Public Library of Science 2017-02-09 /pmc/articles/PMC5300153/ /pubmed/28182700 http://dx.doi.org/10.1371/journal.pone.0171294 Text en © 2017 Montané et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Montané, Eva Barriocanal, Ana Maria Arellano, Ana Lucía Valderrama, Angelica Sanz, Yolanda Perez-Alvarez, Nuria Cardona, Paula Vilaplana, Cristina Cardona, Pere-Joan Pilot, double-blind, randomized, placebo-controlled clinical trial of the supplement food Nyaditum resae(®) in adults with or without latent TB infection: Safety and immunogenicity |
title | Pilot, double-blind, randomized, placebo-controlled clinical trial of the supplement food Nyaditum resae(®) in adults with or without latent TB infection: Safety and immunogenicity |
title_full | Pilot, double-blind, randomized, placebo-controlled clinical trial of the supplement food Nyaditum resae(®) in adults with or without latent TB infection: Safety and immunogenicity |
title_fullStr | Pilot, double-blind, randomized, placebo-controlled clinical trial of the supplement food Nyaditum resae(®) in adults with or without latent TB infection: Safety and immunogenicity |
title_full_unstemmed | Pilot, double-blind, randomized, placebo-controlled clinical trial of the supplement food Nyaditum resae(®) in adults with or without latent TB infection: Safety and immunogenicity |
title_short | Pilot, double-blind, randomized, placebo-controlled clinical trial of the supplement food Nyaditum resae(®) in adults with or without latent TB infection: Safety and immunogenicity |
title_sort | pilot, double-blind, randomized, placebo-controlled clinical trial of the supplement food nyaditum resae(®) in adults with or without latent tb infection: safety and immunogenicity |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5300153/ https://www.ncbi.nlm.nih.gov/pubmed/28182700 http://dx.doi.org/10.1371/journal.pone.0171294 |
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