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

Last updated: September 3, 2017
Sponsor: Fundació Institut Germans Trias i Pujol
Overall Status: Active - Recruiting

Phase

2/3

Condition

Hiv

Lung Disease

Treatment

N/A

Clinical Study ID

NCT02897180
NYADAGEORG
  • Ages > 5
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have completed the written informed consent process prior to undergoing any screeningevaluations.

  2. Have ability to complete follow-up period as required by the protocol.

  3. Willing to allow the investigators to discuss the subject's medical history with thesubject's health care provider.

  4. Close contact of an active TB case not eligible for chemoprophylaxis.

Exclusion

Exclusion Criteria:

  1. Investigator assessment of lack of understanding or willingness to participate andcomply with all requirements of the trial protocol.

  2. Any other finding which in the opinion of the investigator would compromise theprotocol compliance or significantly influence the interpretation of results on theeffects of the vaccine.

  3. Being eligible for chemoprophylaxis (children of <5 years old and HIV-positive adults)

  4. Pregnancy or lactation

  5. Hypersensitivity to mannitol

  6. Suffering active TB

Study Design

Total Participants: 3300
Study Start date:
March 10, 2017
Estimated Completion Date:
March 31, 2021

Study Description

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.

Connect with a study center

  • National Center for Tuberculosis and Lung Diseases

    Tbilisi,
    Georgia

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.