Investigating lung microbiome and immune responses in tuberculosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the lung microbiome and its metabolic products in patients with active pulmonary tuberculosis (TB) before and after treatment. Researchers will collect samples from the lung and compare the microbiome at the site of disease to other body sites, such as the oral cavity and gut. Additionally, blood samples will be taken to assess immune responses related to the microbiome. The study will track changes over time, including at the end of treatment and one year later, to better understand the role of the microbiome in TB outcomes, particularly in the context of HIV.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Less than 18 years or older than 60 years of age.
* Has already initiated TB treatment.
* Rifampicin resistant.
* Has a previous history of TB.
* Bilateral TB disease defined as both lungs with extensive TB disease
* Has received probiotics, antibiotics or inhaled steroids within three months prior to enrolment (not applicable to sick controls)
* Has diabetes mellitus, which affects TB disease, treatment response, and the microbiome
* 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

Where it's running

• Kraaifontein Community Health Centre
  Cape Town, Western Cape, South Africa Recruiting
• Scottsdene Clinic
  Cape Town, Western Cape, South Africa Recruiting
• Wallacedene Clinic
  Cape Town, Western Cape, South Africa Recruiting

Study contacts

• Principal investigator: Grant Theron, PhD — University of Stellenbosch
• Study coordinator: Grant Theron, PhD
• Email: gtheron@sun.ac.za
• Phone: (+27) 021 938 9693

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.