Tuberculosis - Learning the Impact of Nutrition (TB-LION)
Tuberculosis, Malnutrition, Helminth Infection
About this trial
This is an interventional basic science trial for Tuberculosis focused on measuring blood signature of Tb risk, anti Mtb immunity, RNA biomarkers, RePORT Study, India
Eligibility Criteria
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)
Sites / Locations
- Jawaharlal Institute of Postgraduate Medical Education and Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
No Intervention
Malnourished without lung parasites
Malnourished with lung parasites
Well-nourished with lung parasites
Well-nourished without lung parasites
Thirty study participants, household contacts of an index TB case, who are malnourished and do not have lung parasites will be consented into the study intervention. The household contact and the rest of the household members will receive nutritional supplementation meals for six months. The family will receive the food in biweekly installments and will be given a vegan meal plan.The consented household contact will also receive a daily multivitamin.
Thirty study participants, household contacts of an index TB case, who are malnourished and have lung parasites will be consented into the study intervention. The household contact and the rest of the household members will receive nutritional supplementation meals for six months. The family will receive the food in biweekly installments and will be given a vegan meal plan. The consented household contact will also receive a daily multivitamin. These thirty study participants will be given anti-parasitic medications such as albendazole, ivermectin, metronidazole, or other medication per Indian guidelines to treat the parasite infection.
These thirty study participants will be given anti-parasitic medications such as albendazole, ivermectin, metronidazole, or other medication per Indian guidelines to treat the parasite infection.
These thirty study participants will serve as the control.These participants will be well-nourished and not have a parasite infection; therefore, they will not receive the nutritional supplementation or treatment for parasite infection.