Actively Recruiting

Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT04700579

Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis

Led by University of Stellenbosch · Updated on 2026-05-06

150

Participants Needed

3

Research Sites

356 weeks

Total Duration

On this page

Sponsors

U

University of Stellenbosch

Lead Sponsor

N

New York University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The diverse microbial communities in different parts of the human body (microbiome) are important for health but understudied in pulmonary tuberculosis (TB), which is the single biggest infectious cause of death in the world. The investigators will study the site-of-disease microbiome (in the lung bronchoalveolar space) in TB cases to investigate how, before TB treatment, metabolic compounds made by microbes affect host biomarkers important for TB control. The investigators will ask this question again at the end-of-treatment and one year later. Specifically, the investigators will sample the lung at the active TB hotspot identified by imaging and compare this to a non-involved lung segment usually in the opposite lung. The investigators will compare the lung microbiome to other sites in the body (i.e. oral cavity, nasopharynx, supraglottis, and gut). A small amount of blood (\~15 ml) will be collected to assess peripheral immunological correlates of the host microbiome. Protected specimen brushings of the lung will be used to explore transcriptomic signatures and how these relate to the lung microbiome. The investigators will also apply these questions to the same number of controls (healthy patients and patients with an alternative diagnoses). This will lay the foundation for clinical trials to evaluate if specific bacteria have diagnostic (e.g., PCR) or therapeutic potential (e.g., antibiotics, prebiotics, probiotics, vaccines) where targeting the microbiome could improve clinical outcomes.

CONDITIONS

Official Title

Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 60 years
  • Agree to have chest X-ray (CXR) and/or CT scan
  • Have unilateral TB disease with clear evidence in one lung (not applicable for healthy controls; sick controls need another diagnosis)
  • No prior TB treatment and no obvious signs of past TB on chest imaging
  • Willing to undergo research bronchoscopy at baseline, 6 months, and 18 months and likely to stay in the area during the study
  • If HIV-positive, stable on antiretroviral therapy (ART) for at least 1 year
  • Able and willing to return for follow-up visits without plans to move soon
  • Willing to comply with study requirements and provide informed consent
Not Eligible

You will not qualify if you...

  • Younger than 18 or older than 60 years
  • Already started TB treatment
  • Rifampicin resistant TB
  • Previous history of TB
  • Bilateral TB disease affecting both lungs extensively
  • Use of probiotics, antibiotics, or inhaled steroids within 3 months before enrollment (except sick controls)
  • Diabetes mellitus
  • Contraindications for bronchoscopy such as low lung function (FEV1 <70%)
  • Daily alcohol intake exceeding 6 beers or 4 mixed drinks
  • Pregnant or planning pregnancy during the study
  • Recent hospitalization for any reason

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Kraaifontein Community Health Centre

Cape Town, Western Cape, South Africa, 7570

Actively Recruiting

2

Scottsdene Clinic

Cape Town, Western Cape, South Africa, 7570

Actively Recruiting

3

Wallacedene Clinic

Cape Town, Western Cape, South Africa, 7570

Actively Recruiting

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Research Team

G

Grant Theron, PhD

CONTACT

C

Charissa Naidoo, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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