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

Launched by UNIVERSITY OF STELLENBOSCH · Jan 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how the bacteria and other tiny organisms (the microbiome) in the lungs and other parts of the body affect people with active tuberculosis (TB), a serious lung infection. Researchers want to understand how these microorganisms change before and after TB treatment and how they relate to the body’s immune response. They will collect samples from the lungs and other areas, such as the mouth and gut, to see if certain bacteria could help doctors diagnose or treat TB more effectively in the future.

To participate in this trial, you need to be between 18 and 60 years old and have active TB in one lung. You must be willing to undergo imaging tests and several lung procedures over the study period. If you are living with HIV, you should be stable on treatment for at least a year. Participants will provide blood samples and undergo bronchoscopy, which is a procedure to look inside the lungs, at different points during the study. This research aims to deepen our understanding of TB and possibly lead to better treatment options down the line.

Gender

ALL

Eligibility 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