Investigating lung microbiome and immune responses in tuberculosis patients
Pre- and Post-treatment Lung Microbiota, Metabolome and Immune Signatures at the Site of Disease in Patients With Active Pulmonary Tuberculosis
This study looks at the lung bacteria and immune responses in people with active tuberculosis to see how they change before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of Stellenbosch Academic / other |
| Locations | 3 sites (Cape Town, Western Cape and 2 other locations) |
| Trial ID | NCT04700579 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-60 with unilateral active TB disease who have not received prior TB treatment.
Not a fit: Patients with bilateral TB disease or those who have already initiated TB treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into how the microbiome influences TB treatment outcomes, potentially improving patient care.
How similar studies have performed: While few studies have focused on the lung microbiome in TB, existing research suggests that microbiome interactions can significantly impact disease outcomes, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cape Town, Western Cape and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.