NCT02897180

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

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.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 3,300 (estimated)
• Sponsor: Fundació Institut Germans Trias i Pujol · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Close Contacts of Active Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	Nyaditum resae(R)	Capsules containing Nyaditum resae(R)
BIOLOGICAL	Placebo	Capsules containin Placebo

Timeline

• Start date: 2017-03-10
• Primary completion: 2020-10-01
• Completion: 2021-03-01
• First posted: 2016-09-13
• Last updated: 2017-09-07

Locations

1 site across 1 country: Georgia