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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

3300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2021-03-31

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.

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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.

Conditions

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Close Contacts of Active Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Subjects will receive a total of 14 capsules with Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Capsules containin Placebo

Nyaditum resae(R)

Subjects will receive a total of 14 capsules with Nyaditum resae(R)

Group Type EXPERIMENTAL

Nyaditum resae(R)

Intervention Type BIOLOGICAL

Capsules containing Nyaditum resae(R)

Interventions

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Nyaditum resae(R)

Capsules containing Nyaditum resae(R)

Intervention Type BIOLOGICAL

Placebo

Capsules containin Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Have completed the written informed consent process prior to undergoing any screening evaluations.
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 the subject's health care provider.
4. Close contact of an active TB case not eligible for chemoprophylaxis.

Exclusion Criteria

1. Investigator assessment of lack of understanding or willingness to participate and comply with all requirements of the trial protocol.
2. 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.
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

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes