Efficacy of Nyaditum Resae(R) Against Active TB in Georgia

Study Overview
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Brief Summary
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The use of a supplement food like Nyaditum resae is a reliable opportunity to stop the progression towards active TB through the most updated knowledge of this disease:the induction of tolerance. In order to demonstrate the percentage of efficacy of this approach, different studies must be run to elucidate the percentage of protection in different setting all over the world. The strategy is to establish its efficacy through a simple clinical trial, aimed just to know the incidence of TB in Placebo and NR treated contacts of active TB cases.

Detailed Description
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Evaluation of a supplement food Nyaditum resae in the uincidence of TB. This is a ranzomized doube-blind controlled clinical trial to evaluate the efficacy and safety of a supplememt food in comparison to placebo in TB.

Official Title
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Double-blind, Randomized, Masked, Placebo-controlled, Clinical Trial to Investigate the Efficacy of the Nutraceutical Nyaditum Resae(R) Administered to Contacts of Active Tuberculosis in Georgia.

Conditions
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Close Contacts of Active Tuberculosis

Intervention / Treatment
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* Biological: Nyaditum resae(R)
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have completed the written informed consent process prior to undergoing any screening evaluations. Have ability to complete follow-up period as required by the protocol. Willing to allow the investigators to discuss the subject's medical history with the subject's health care provider. Close contact of an active TB case not eligible for chemoprophylaxis. Exclusion Criteria: Investigator assessment of lack of understanding or willingness to participate and comply with all requirements of the trial protocol. Any other finding which in the opinion of the investigator would compromise the protocol compliance or significantly influence the interpretation of results on the effects of the vaccine. Being eligible for chemoprophylaxis (children of <5 years old and HIV-positive adults) Pregnancy or lactation Hypersensitivity to mannitol Suffering active TB

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Subjects will receive a total of 14 capsules with Placebo | Biological: Placebo<br>* Capsules containin Placebo<br>|
| Experimental: Nyaditum resae(R)<br>Subjects will receive a total of 14 capsules with Nyaditum resae(R) | Biological: Nyaditum resae(R)<br>* Capsules containing Nyaditum resae(R)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, incidence of confirmed cases of active TB | The primary endpoint is to assess the incidence of active TB: confirmed TB cases (including extrapulmonary TB) as described as: Clinical, radiology or histology evidence compatible with active TB plus validated Molecular Biology tests POSITIVE, or culture POSITIVE. The GeneXpert MTB/RIF system will be used as molecular diagnostic test to identify M. tuberculosis in this trial. Although this, in case a patient is diagnosed using any other validated method (i.e.: diagnosed in a site not participating in the trial), this could be accepted if well documented Cultures will be done using validated methodologies, including both solid and liquid cultures. An independent Endpoint Committee will be created to confirm all the TB cases. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy, incidence of all cases of active TB and mortality (all causes) | 1. Incidence of all TB: suspected and clinical active TB, defined as: • Suspected active TB: Do not meet the confirmed criteria but have compatible Clinical or Radiological or Pathological examinations AND supportive Microbiology (AFB positive) or non-validated Molecular Biology positive evaluations. • Clinical active TB: In the data collected, physician starts treatment without any supporting evidence of suspected or confirmed TB. | 2 years | 
| Incidence of adverse events during the administration of the NR | Number of adverse events in both arms | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food supplement, tuberculosis, latent tuberculosis infection, Mycobacterium manresensis, Nyaditum resae, Efficacy trial