Status:
ACTIVE_NOT_RECRUITING
Nyaditum Resae® as a Co-adjuvant During Treatment for Active Pulmonary Tuberculosis and Its Impact on the Gut Microbiota
Lead Sponsor:
University of Stellenbosch
Collaborating Sponsors:
Fundació Institut Germans Trias i Pujol
Conditions:
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 improvin...
Detailed Description
About one tenth of the 1.7 billion individuals infected with Mycobacterium tuberculosis (Mtb) will progress to active tuberculosis (TB). This probability increases in people with human immunodeficienc...
Eligibility Criteria
Inclusion
- 18-65 years
- New cases
- Sputum Xpert Ultra (Xpert) positive for Mycobacterium tuberculosis
- Have not initiated TB treatment
- If HIV-positive, are stable on antiretroviral therapy
Exclusion
- Resistance to any of the first-line drugs (Xpert rifampicin-resistant)
- Previous TB
- Diabetes mellitus
- Taking immunomodulatory drugs (e.g. cancer chemotherapy, tumour necrosis factor (TNF) inhibitors or other anti-inflammatory medication, phosphodiesterase inhibitors, corticosteroids within the past 6 months, and cholesterol-lowering drugs)
- Pregnant or lactating women
- Chronic hepatitis
Key Trial Info
Start Date :
May 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03851159
Start Date
May 10 2019
End Date
December 31 2025
Last Update
May 16 2025
Active Locations (2)
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1
Scottsdene Clinic
Cape Town, Western Cape, South Africa, 7570
2
Wallacedene Clinic
Cape Town, Western Cape, South Africa, 7570