Active — Not RecruitingNot Applicable

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

South Africa48 participantsStarted 2019-05-10

Plain-language 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

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Gut microbiome composition in placebo versus experimental arm

Timeframe: Up to 18 months

Trial details

NCT IDNCT03851159

SponsorUniversity of Stellenbosch

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

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