Study to Evaluate the Tolerability and Immunogenicity of Nyaditum Resae ® Probiotic Administered to Pediatric Population in Contact With Tuberculosis With or Without Latent Tuberculosis Infection
Condition: Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Interventional

Summary: 
      This is a doble-blind, masked, compared with placebo clinical trial in pediatric population
      in contact with tuberculosis with or without tuberculosis infection. This trial aims to study
      the effect of the probiotic Nyaditum resae® at the level of specific Treg memory cells eight
      weeks after the first administration, and the global tolerability of the treatment.

      Nyaditum resae® is a preparation in the form of capsules containing heat-killed environmental
      mycobacteria Mycobacterium manresensis. 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 multi-resistance 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 we drink, so that at a greater or lesser extent we already
      have it in our intestinal flora. The second, inducing a tolerant response, like we do when we
      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 our 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 capsules, containing
      a heat-killed Mycobacterium manresensis 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.

      Tolerability of Nyaditum resae® has been studied in adults. Next step is to asses its
      behavior in pediatric population, since is a particularly vulnerable population in countries
      where there is a high incidence of this disease.
    

Intervention name(s): Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis, 1 capsule per day during 14; Placebo, 1 capsule per day during 14
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Tuberculosis; Tregs; Tolerance; Probiotic; Mycobacteria