Nyaditum Resae® as a Co-adjuvant During Treatment for Active Pulmonary Tuberculosis and Its Impact on the Gut Microbiota

NCT03851159 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-05

No results posted yet for this study

Summary

This will be the first study to evaluate the use of Nyaditum resae® as a potential agent for reducing antibiotic-associated gut dysbiosis in patients with drug-susceptible TB, and potentially improving clinical and microbiological markers of outcome

Conditions

Interventions

DIETARY_SUPPLEMENT

Nyaditum resae®

Heat-killed Mycobacterium manresensis

OTHER

Mannitol

Placebo

Sponsors & Collaborators

  • Fundació Institut Germans Trias i Pujol

    collaborator OTHER
  • University of Stellenbosch

    lead OTHER

Principal Investigators

  • Grant Theron, PHD · University of Stellenbosch

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-10
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • South Africa

Study Locations

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Entities

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 NCT03851159 on ClinicalTrials.gov