Can better nutrition and cheap worm treatment stop TB?
NCT ID NCT03598842
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at why some people infected with TB bacteria get sick while others don't. Researchers in India studied 120 household contacts of TB patients, comparing those who were malnourished or had parasitic worms. They provided food and deworming medication to see how these factors change the immune system's response to TB. The goal is to find low-cost ways to prevent active TB.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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786 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Dec 2025
- Lead sponsor
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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.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: Household Contacts * Household contact that has been housemate of eligible index case for at least the last month (See index case criteria below). * HIV seronegative * Willing to be tested for pregnancy if married * Age 18-60 years * Willingness by the patient to attend scheduled follow-up visits and undergo study assessments * Able to provide informed consent * Intervention inclusion: On average, one meal consumed at home per day. Exclusion Criteria: Household Contacts * In the team's judgement, individual is not expected to survive for 12 months * HIV infection or not willing to undergo HIV testing (if no documented HIV test) * Pregnant at enrollment * Known diabetes mellitus or evidence of diabetes on hemoglobin A1C (HA1C) * Xpert positive among those able to produce sputum * TB symptoms (night sweats, weight loss, cough) - Only if sputum positive * Any history of TB disease during their lifetime * We will retrospectively exclude household contacts of presumed TB cases whose cultures do not confirm Mtb or who are Xpert negative. * Evidence of kwashiorkor (pitting edema of foot or lower leg) those with BMI \<16 * Abnormal K, Mg, Phos in those with BMI \<16 Inclusion Criteria: Index Case * Sputum Ziehl-Neelsen stain positive for acid-fast bacillus (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 during the previous one month * Agrees to have household contact notified about study Exclusion Criteria: Index Case * Pregnant at enrollment * No Xpert or culture confirmation and unable to provide sputum sample * No household contacts who share room * Known Multidrug-resistant tuberculosis (MDR-TB) or extensively drug-resistant tuberculosis (XDR-TB) case * BMI \<14 kg/m2 * Abnormal K, Mg, Phos in those with BMI 14 - 16 * Lower extremity edema/kwashiorkor those with BMI 14-16 * Reported neuropathy in lower extremities (may result from thiamine deficiency)
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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
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Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry, Tamil Nadu, India
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Other studies related to the condition(s) this trial covers.
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