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
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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