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

Fundació Institut Germans Trias i Pujol

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Close Contacts of Active Tuberculosis

Treatments: Biological: Nyaditum resae(R); Biological: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02897180

NYADAGEORG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,300 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,300 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects will receive a total of 14 capsules with Placebo

Treatment:

Biological: Placebo

Nyaditum resae(R)

Experimental group

Description:

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

Treatment:

Biological: Nyaditum resae(R)