Safety and Immunogenicity of Nyaditum Resae® Probiotic to Protect From Tuberculosis
|ClinicalTrials.gov Identifier: NCT02076139|
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : February 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis||Dietary Supplement: Nyaditum resae® 10e4 Dietary Supplement: Nyaditum resae® 10e5 Other: Distilled water||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||47 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Pilot Clinical Trial, Double-blind, Randomized, Placebo Controlled and Masked to Evaluate the Tolerability and Immunogenicity of Nyaditum Resae® Probiotic Administered to Adults With or Without Latent Tuberculosis Infection|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||July 2015|
Experimental: Nyaditum resae® 10e4
The subjects will receive 1 drinkable vial (4mL) per day during 14 days. Each vial contains 10e4 Colony-forming units (CFUs) of Nyaditum resae®.
|Dietary Supplement: Nyaditum resae® 10e4|
Experimental: Nyaditum resae® 10e5
The subjects will receive 1 drinkable vial (4mL) per day during 14 days. Each vial contains 10e5 CFUs of Nyaditum resae®.
|Dietary Supplement: Nyaditum resae® 10e5|
Placebo Comparator: Placebo
The subjects will receive 1 drinkable vial (4mL) of distilled water per day during 14 days.
|Other: Distilled water|
- Change from Baseline in Specific Treg memory cells at week 1 [ Time Frame: From Baseline to Week 1 ]Median increase of specific Treg memory cells at week 1.
- Global tolerability of Nyaditum resae ®, proportion of participants with adverse events related to study treatment. [ Time Frame: Baseline to week 6 ]Proportion of patients presenting adverse events related to study treatment.
- Local tolerability (gastrointestinal duct), proportion of participants with gastrointestinal adverse events related to study treatment. [ Time Frame: Baseline to week 6 ]Proportion of participants presenting gastrointestinal adverse events related to study treatment.
- Systemic tolerability (vital signs, physical exam, laboratory tests), proportion of participants with systemic adverse events related to study treatment. [ Time Frame: Baseline to week 6 ]Proportion of participants presenting systemic adverse events related to study treatment.
- Change from Baseline in Specific Treg memory cells at week 2 [ Time Frame: From Baseline to Week 2 ]Median increase of specific Treg memory cells at week 2.
- Change from Baseline in Specific Treg memory cells at month 12 [ Time Frame: From Baseline to Month 12 ]Median increase of specific Treg memory cells at month 12
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076139
|Germans Trias I Pujol Hospital|
|Badalona, Barcelona, Spain, 08916|
|Principal Investigator:||Eva Montané, MD, PhD||Germans Trias i Pujol Hospital|