Tuberculosis - Learning the Impact of Nutrition

Launched by BOSTON MEDICAL CENTER · Jul 16, 2018

Keywords

ClinConnect Summary

The Tuberculosis - Learning the Impact of Nutrition trial is studying how nutrition and the presence of worms (parasites) affect the risk of developing active tuberculosis (TB) in people who live with someone who has TB. The researchers believe that malnutrition and parasites may make it more likely for people to get sick from TB. This study will take place in India, where there are many TB cases each year, and it aims to find out whether improving nutrition and treating worm infections can help prevent TB from developing in healthy individuals who are in close contact with TB patients.

To participate, individuals must be between 18 and 60 years old, live with someone who has TB, and be willing to undergo certain tests and follow-up visits. They should also not have any serious health issues that could prevent them from being in the study. Participants will be divided into groups based on their nutrition status and whether they have worms, and they will receive meals or treatments as needed. The goal is to understand how these factors influence TB risk, potentially leading to better ways to control and prevent TB in the future.

Gender

ALL

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)