Safety and Immunogenicity of Nyaditum Resae® Probiotic to Protect From Tuberculosis
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      This is a double-blind, masked, compared with placebo clinical trial in healthy volunteers
      with or without tuberculosis infection. This trial aims to study the effect of the probiotic
      Nyaditum resae® at the level of specific Regulatory T cells (Treg) memory cells one week
      after the first administration and the global tolerability of the treatment. Nyaditum resae®
      is a preparation in the form of drinkable vials containing heat-killed environmental
      mycobacteria. The overall objective of the study is the effect of Nyaditum resae® on
      immunity, which could reduce the risk of developing active tuberculosis.
    

Detailed description: 
      The incidence of tuberculosis is still a problem of the first magnitude. Every year 1.5
      million people die; there are 10 million cases of illness and 100 million new infected. The
      growing problem of multiresistance is to be added, remaining so prevalent: 700,000 patients,
      a figure that increases annually with 100,000 people. Prevention of tuberculosis is currently
      very difficult because it is a disease caused by a bacillus (Mycobacterium tuberculosis) that
      is transmitted by air: No risk factor for becoming infected has been identified and there is
      still no prophylactic vaccine that prevents from infection. One of the most characteristic
      aspects of tuberculosis is that the majority (90-95 %) of people without immunity alterations
      do not develop the disease after being infected. As for people who do develop the disease, it
      is still not known why they develop it.

      A group of researchers from the Institut Germans Trias i Pujol recently discovered a
      mechanism that explains this trend. In short, what happens is that certain people create a
      too strong inflammatory response against tuberculosis bacillus, which ends up creating
      massive destruction of the tissue that is around the bacillus and brings the characteristic
      lesion of tuberculosis: tuberculous cavity.

      This group of researchers was devising ways to "reeducate" the immune system against the
      bacillus not make it aggressive. And they did it using two instruments. The first one, an
      environmental mycobacteria, namely a bacillus of the family of mycobacteria tuberculosis,
      that usually lives in the water they drink, so that at a greater or lesser extent the
      investigators already have it in their intestinal flora. The second, inducing a tolerant
      response, like the investigators do when they eat food. To induce a tolerant response, low
      and repeated doses of the product make the immune system of the digestive duct "used to"
      their presence. Thus, when it becomes to find the product, the immune system reacts in a very
      light and balanced manner, avoiding excessive inflammatory responses. The clearest example is
      the fact that their immune system "is used" to feed proteins and generates no rejection
      answers found in the intestinal mucosa.

      Hence comes the probiotic Nyaditum resae®, a preparation in the form of drinkable vials,
      containing a heat-killed environmental mycobacteria and thus can generate a cross-immunity
      with the tuberculosis bacillus. By giving low and repeated dose to generate a tolerant
      response, which happens when there is an infection by Mycobacterium tuberculosis, so that a
      balanced immune response is triggered able to reduce the risk of developing active
      tuberculosis.
    

Intervention name(s): Nyaditum resae® 10e4; Nyaditum resae® 10e5; Distilled water
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: tuberculosis; treg; tolerance; probiotic; mycobacteria