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Could a simple stool test revolutionize TB diagnosis for kids and HIV patients?

NCT ID NCT05047315

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study evaluated a new stool-based test (qPCR) to diagnose tuberculosis (TB) in children under 8 and people living with HIV. Researchers in Mozambique, Eswatini, and Uganda tested nearly 2,000 participants to see if the stool test could improve TB detection rates compared to standard methods like sputum tests. The goal is to make TB diagnosis easier and more accessible for those who are often missed.

What this could mean

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

Active substance
stool-based qPCR diagnostic test
What this could lead to
If successful, this could provide a simpler, non-invasive way to diagnose tuberculosis in hard-to-test groups like children and people with HIV, potentially increasing detection rates.
What could go wrong
This is a completed diagnostic accuracy study, not a treatment trial. The test may not be accurate enough in real-world settings, and it does not directly improve health outcomes.

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

1,967 people

The number who actually took part.

Started

Dec 2021

Finished

Jun 2025

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

Our proposed diagnostic evaluation will be performed in three high TB/HIV burden settings in populations where the tests are intended to be used (presumptive adult pulmonary TB cases and presumptive intrathoracic pediatric TB cases). The study will enroll presumptive TB cases within two study groups: 1. Children less than 8 years of age (irrespective of HIV status) 2. Adults living with HIV (\>15 years of age), irrespective of immunological status.

Ages

0 to 8 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: Pediatric Cohort * \<8 years of age * Identified with suspected PTB defined as follows: 1. A child with ≥1 of the following criteria: <!-- --> 1. Persistent unremitting cough (or cough significantly worse than usual in child with chronic lung disease including HIV-related) of \>2 weeks duration, unresponsive to a course of appropriate antibiotics (when clinically indicated) 2. Poor growth documented over the preceding 3 months \[clear deviation from a previous growth trajectory and/or documented crossing of centile lines in the preceding 3 months and/or; weight-for-age, or weight-for-height Z-score of ≤2 in the absence of information on previous/recent growth trajectory AND not responding to nutritional rehabilitation (or to antiretroviral therapy if HIV-infected)\] 3. Persistent unexplained lethargy or reduced playfulness/activity reported by the caregiver. 4. Persistent (\>1w) unexplained fever (\>38C), reported by a guardian or objectively recorded at least once; 5. In infants 0-60 days, also: unresponsive neonatal pneumonia or unexplained hepatosplenomegaly OR sepsis-like illness (all other more common causes excluded and/or not responding to appropriate therapy/ broad-spectrum antibiotics/antivirals). OR 2\) Any duration of cough/ wheeze/ acute pneumonia with ≥1: 1. TB exposure. Either: i) Documented/Reported exposure to a known TB source case (regardless of smear status) in previous 12months OR ii) immunological evidence: positive IGRA or positive TST (defined as \>5mm in HIV infected or severely malnourished, \>10 otherwise) 2. Chest radiograph suggestive of TB. Adult Cohort (WHO definition of a HIV-positive presumptive TB case) * \> 15 years of age * Confirmed HIV infection (ELISA or molecular) * Presenting at any health facility with any of the following: cough, fever, night sweats or unintentional weight loss (any duration). Exclusion criteria Participants will be excluded (both from study groups) if: * Receiving TB treatment for \>72 hours in previous 2 weeks * History of TB treatment in the last year * Refusal to provide consent for study participation or HIV testing when status is unknown * Severe illness resulting in unstable condition * Absolute contra-indication to any of sampling procedures required by the study (ie: acute severe asthma, pertussis syndrome etc.)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Baylor Eswatini Clinical Centre of Excellence (COE)

    Mbabane, Eswatini

  • Centro de investigação de Saúde de Manhiça

    Manhiça, Maputo Province, 1929, Mozambique

  • Makerere University

    Kampala, Uganda

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