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Hidden gut infections may sabotage TB recovery, study suggests

NCT ID NCT05048485

Knowledge-focused Sponsor: Boston Medical Center Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 141 people being treated for tuberculosis (TB) to see if intestinal parasites or poor nutrition made their recovery harder. Researchers checked stool samples for parasites and measured weight gain and treatment success. Some participants received nutritional supplements for 6 months. The goal was to understand how these factors affect TB outcomes, not to test a new drug.

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 research could point to ways to improve TB treatment outcomes by addressing parasite infections and malnutrition.
What could go wrong
This is an observational study, not a treatment trial. It cannot prove cause and effect, 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

141 people

The number who actually took part.

Started

Apr 2022

Finished

Jul 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

The study population is newly diagnosed smear-positive (\>/=1+ AFB) pulmonary TB patients living in Puducherry and Tamil Nadu.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Sputum Ziehl-Neelsen stain positive for AFB (≥1+) * Culture or Xpert positive for Mtb; those who are smear+ but ultimately Xpert or culture negative, will be included until their culture results return at which time they will retrospectively be removed from the study. * No history of TB treatment (i.e., no history of partial or complete treatment for a previous TB episode) * Has at least 1 household contact with whom they have shared a house with during the previous one month * Agrees to have household contact notified about study Exclusion Criteria: * Household contact ineligible for TB LION study * Pregnant at enrollment * Previously diagnosed with diabetes or hemoglobin A1c\>6.5% on testing * No Xpert or culture confirmation and unable to provide sputum sample * Known multidrug-resistant tuberculosis (MDR) or extensively drug resistant (XDR) TB case at recruitment or found at time of enrollment * BMI \<14 kg/m2 * Lower extremity edema/kwashiorkor * Reported neuropathy in lower extremities (may result from thiamine deficiency)

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Conditions

The condition(s) this trial relates to.

helminthiasis Malnutrition nutritional deficiency disease pulmonary tuberculosis

As listed by the trial registrant

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

Helminthiasis Malnutrition Tuberculosis, pulmonary

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Jawaharlal Institute of Postgraduate Medical Education and Research

    Puducherry, 605006, India

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