NCT03598842Completed
Tuberculosis - Learning the Impact of Nutrition
Tuberculosis- Learning the Impact of Nutrition
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
The proposed work is based on the finding that one-third of the world is infected with the bacteria Mycobacterium tuberculosis (Mtb) and only 10% of these individuals develop TB. The study aims to identify factors that drive progression to disease and study signals (markers of the immune response) that detect who will progress to active TB and why this happens. Armed with these markers, the study will address how malnutrition and worms alter this signal profile to cause active TB. The work will be conducted in India, where there are 2.8 million TB cases each year - more than any other country - and where the government has committed to eliminating TB by 2035. Data suggest that malnutrition and parasites increase risk of TB disease so the investigators will feed malnourished household contacts and have those with parasites receive medication to treat these. Using this infrastructure, the investigators will evaluate the immunologic impact of feeding on TB pathogenesis. An additional aim is to understand the role of parasitic worms with the goal of determining the utility of low-cost ($.02 per dose) worm treatment as part of TB control efforts. Risk of developing TB will be evaluated for 120 household contacts of TB patients in the setting of their malnutrition and parasites. There are four study arms comprised of thirty participants each -- malnourished with parasite infection, malnourished with no parasite infection, well-nourished with parasite infection, and well-nourished with no parasite infection. Correlates of risk of disease will be assessed using blood messenger RNA/micro RNA (mRNA/miRNA) sequencing and T cell immune markers. The TB LION study will confirm that malnutrition and worms increase the risk of active TB and will provide the basis for effective interventions that could change the face of the TB pandemic and have a profound impact on the health of people worldwide. Participants in this study will be household contacts of tuberculosis index cases. The index cases in this study do not participate in the study once a household contact is established. All interventions and follow up are only being conducted within the household contact cohort. All intervention supplies, treatments, and biologics will be purchased internationally.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 786 (actual)
- First submitted
- 16 Jul 2018
- Start date
- 12 Jul 2019
- Primary completion date
- 29 Dec 2025
- Lead sponsor
- Boston Medical Center
- Diseases
- Tuberculosis
- NCT number
- NCT03598842
What you commit to
- Study type: Interventional
- Participants enrolled: 786
- From 12 Jul 2019 to the primary completion date, 29 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- HIV infection or not willing to undergo HIV testing (if no documented HIV test)
- Any history of TB disease during their lifetime
- Known Multidrug-resistant tuberculosis (MDR-TB) or extensively drug-resistant tuberculosis (XDR-TB) case
Lab values
- Known diabetes mellitus or evidence of diabetes on hemoglobin A1C (HA1C)
Other
- In the team's judgement, individual is not expected to survive for 12 months
- Pregnant at enrollment
- Xpert positive among those able to produce sputum
- TB symptoms (night sweats, weight loss, cough) - Only if sputum positive
- 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
- Pregnant at enrollment
- No Xpert or culture confirmation and unable to provide sputum sample
- No household contacts who share room
- 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)
Who the study is looking for
- 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.
- 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
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jawaharlal Institute of Postgraduate Medical Education and Research Coordinator of this site? Confirm its status | Pondicherry | India | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.