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Safety and Immunogenicity of Nyaditum Resae® Probiotic to Protect From Tuberculosis

NCT02076139 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2018-10-31

No results posted yet for this study

Summary

This is a double-blind, masked, compared with placebo clinical trial in healthy volunteers with or without tuberculosis infection. This trial aims to study the effect of the probiotic Nyaditum resae® at the level of specific Regulatory T cells (Treg) memory cells one week after the first administration and the global tolerability of the treatment. Nyaditum resae® is a preparation in the form of drinkable vials containing heat-killed environmental mycobacteria. The overall objective of the study is the effect of Nyaditum resae® on immunity, which could reduce the risk of developing active tuberculosis.

Conditions

Interventions

DIETARY_SUPPLEMENT

Nyaditum resae® 10e4

DIETARY_SUPPLEMENT

Nyaditum resae® 10e5

OTHER

Distilled water

Sponsors & Collaborators

  • Manresana de Micobacteriologia, SL

    lead INDUSTRY

Principal Investigators

  • Eva Montané, MD, PhD · Germans Trias i Pujol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-06-30
Completion
2015-07-31

Countries

  • Spain

Study Locations

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Entities

Diseases

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 NCT02076139 on ClinicalTrials.gov