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

NCT02897180 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 3300

Last updated 2017-09-07

No results posted yet for this study

Summary

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.

Conditions

  • Close Contacts of Active Tuberculosis

Interventions

BIOLOGICAL

Nyaditum resae(R)

Capsules containing Nyaditum resae(R)

BIOLOGICAL

Placebo

Capsules containin Placebo

Sponsors & Collaborators

  • National Center for Tuberculosis and Lung Disease, Tbilisi, Georgia

    collaborator OTHER

  • Fundació Institut Germans Trias i Pujol

    lead OTHER

Principal Investigators

  • Pere-Joan Cardona, MD, PhD, Pr · Fundacio Institut Germans Trias i Pujol (IGTP)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-10
Primary Completion
2020-10-31
Completion
2021-03-31

Countries

  • Georgia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02897180 on ClinicalTrials.gov