NCT04700579Recruiting
Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 28 Dec 2020
- Start date
- Mar 2021
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Stellenbosch
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT04700579
What you commit to
- Study type: Observational
- Planned participants: 150
- From Mar 2021 to the primary completion date, Dec 2026
- 3 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
- Has a previous history of TB.
- Has received probiotics, antibiotics or inhaled steroids within three months prior to enrolment (not applicable to sick controls)
Other illness
- Bilateral TB disease defined as both lungs with extensive TB disease
- Has diabetes mellitus, which affects TB disease, treatment response, and the microbiome
Age
- Less than 18 years or older than 60 years of age.
Other
- Has already initiated TB treatment.
- Rifampicin resistant.
- Has a contraindication for bronchoscopy (e.g., FEV1 \<70%), as determined by bronchoscopists according to best practice guidelines
- Has a daily alcohol intake of more than 6 beers or 4 mixed drinks
- Is pregnant (a commercial human chorionic gonadotropin determination assay will be performed in accordance with manufacturer's guidance on urine) or pregnancy planned for follow-up period
- Recent hospitalization for any reason
Who the study is looking for
- 18-60 years old.
- Agree to undergo CXR and/or CT scan.
- Has unilateral TB disease defined as one lung with extensive evidence of TB disease (non-applicable to healthy controls; sick controls will require an alternative diagnosis).
- No evidence of prior TB treatment and/or CXR/CT does not have obvious evidence of prior TB.
- Willing to undergo a research bronchoscopy at baseline, 6 months and 18 months and likely to remain in the area for the study period.
- If HIV-positive, must be stable on antiretroviral therapy (ART) for ≥1 year.
- Able and willing to return for follow-up visits, with no plans to move in the near future.
- Willing to comply with study requirements i.e. provision of contact details and written, informed consent prior to enrolment.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (3)
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 | Recruiting |
| Kraaifontein Community Health Centre Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
| Scottsdene Clinic Coordinator of this site? Confirm its status | Cape Town | South Africa | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.