CompletedNot Applicable

Potential Role of Microbiome in Tuberculosis

Pakistan450 participantsStarted 2021-08-22

Plain-language summary

Tuberculosis (TB), caused by Mycobacterium tuberculosis (Mtb), is a deadly infectious disease and major global public health problem. Recent evidence from animal studies suggests that the microbiome plays a role in TB pathogenesis and immune response. However, until now, no similar study has been performed in humans and thus any influence of the microbiota on TB or vice versa remains unknown.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Diagnosed with TB after detailed history collection, clinical examination and laboratory assessment (sputum culture positive).
✓. Aged 18 - 65 years.
✓. Willing to participate in the study.
✓. Healthy controls are those who are free of TB symptoms, healthy on physical examination and with a negative sputum culture result.

Exclusion criteria

✕. Already on anti-TB treatment or previously treated for TB.
✕. Severely anemic (Hb \< 10g/dL).
✕. Having diarrhea or other major gastrointestinal disorders.
✕. Using or have used aminoglycoside or quinolones antibiotics in the past one month.
✕. Using a medically prescribed diet or nutrition supplement.
✕. Pregnant or lactating women.
✕. Patients with liver or renal dysfunction, or having any other chronic disease condition.
✕. Multidrug resistance TB patients

What they're measuring

Gut microbiome diversity and functional potential

Timeframe: 2 Years

Trial details

NCT IDNCT04985994

SponsorKhyber Medical University Peshawar

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-31

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