NCT03851159Active, not recruiting
Nyaditum Resae® as a Co-adjuvant During Treatment for Active Pulmonary Tuberculosis and Its Impact on the Gut Microbiota
Nyaditum Resae® (a Food Supplement) as a Co-adjuvant During First-line Treatment for Active Pulmonary Tuberculosis and Its Impact on the Gut Microbiota - a Pilot Double-blind Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 48 (actual)
- First submitted
- 19 Feb 2019
- Start date
- 10 May 2019
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Stellenbosch
- Diseases
- Tuberculosis
- NCT number
- NCT03851159
What you commit to
- Study type: Interventional
- Participants enrolled: 48
- From 10 May 2019 to the primary completion date, 31 Dec 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Resistance to any of the first-line drugs (Xpert rifampicin-resistant)
- Previous TB
Other illness
- 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)
- Chronic hepatitis
Other
- Pregnant or lactating women
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wallacedene Clinic Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Scottsdene Clinic Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.