Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets

Completed

Conditions studied: Tuberculosis, Pulmonary, Helminthiasis, Malnutrition

In brief

The objectives of this research are to determine: * the burden of intestinal parasitic infections among persons living with pulmonary tuberculosis (TB) * whether intestinal parasitic infections alter TB treatment outcomes, including speed of sputum clearance and treatment outcomes * the impact of malnutrition on speed of sputum clearance and TB treatment outcomes * whether nutritional supplementation improves speed of sputum clearance and treatment outcomes In this study the researchers will investigate how intestinal parasites impact the nutritional status of TB patients before the start of nutritional supplementation and how they alter the trajectory of weight gain in those receiving supplementation by analyzing results from 2 cohorts. LEOPARD Cohort 1- * Control-Enroll TB cases, screen for undernutrition, obtain stool for intestinal parasite screening by polymerase chain reaction (PCR), and assess them for treatment outcomes and weight gain * TB LION (Learning Impact of Nutrition) - Enroll TB cases, provide nutritional supplementation for 6 months (as part of existing TB LION study), screen for undernutrition, obtain stool for intestinal parasite screening by PCR, and assess them for treatment outcomes and weight gain LEOPARD Cohort 2 - * Enroll TB cases, screen for undernutrition, obtain stool for internal parasite screening by PCR, and assess them for treatment outcomes and weight gain.

Key facts

Study ID

NCT05048485

Run by

Boston Medical Center

People needed

141

Starts

2022-04-09

Expected to finish

2025-07-21

Last updated by the study team

2025-11-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States
• Jawaharlal Institute of Postgraduate Medical Education and Research — Puducherry, India

Full record on ClinicalTrials.gov

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