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Scientists probe lung microbiome to unlock TB secrets

NCT ID NCT04700579

Knowledge-focused Sponsor: University of Stellenbosch Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at the bacteria living in the lungs of people with active tuberculosis (TB) and how they change with treatment. Researchers will compare lung bacteria in diseased and healthy areas, and also check the mouth, nose, and gut. They aim to understand how these microbes influence the body's immune response and recovery. The goal is to find new ways to diagnose or treat TB by targeting the lung microbiome.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could point toward new ways to diagnose or treat TB by targeting the lung microbiome.
What could go wrong
This is an observational study, not a treatment trial. It may not lead directly to new therapies, and results may not apply to all TB patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Self-presenting patients with Xpert MTB/RIF Ultra-confirmed TB (n=50, equally stratified by HIV) and culture negative HHCs (n=50, equally stratified by HIV) will be recruited from primary care clinics (Scottsdene and Wallacedene) in Cape Town, South Africa. An additional 50 sick controls with other lung diseases will be referred from Tygerberg Academic Hospital.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

AIDS latent tuberculosis infection pulmonary tuberculosis tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HIV/AIDS TB - tuberculosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kraaifontein Community Health Centre

    RECRUITING

    Cape Town, Western Cape, 7570, South Africa

  • Scottsdene Clinic

    RECRUITING

    Cape Town, Western Cape, 7570, South Africa

  • Wallacedene Clinic

    RECRUITING

    Cape Town, Western Cape, 7570, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.