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Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets

NCT05048485 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 141

Last updated 2025-11-04

No results posted yet for this study

Summary

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.

Conditions

  • Tuberculosis, Pulmonary
  • Helminthiasis
  • Malnutrition

Sponsors & Collaborators

  • Jawaharlal Institute of Postgraduate Medical Education & Research

    collaborator OTHER_GOV

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Pranay Sinha, MD · Boston Medical Center

  • Pakrash Babu Narasimhan, PhD · Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-09
Primary Completion
2025-07-21
Completion
2025-07-21

Countries

  • United States
  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05048485 on ClinicalTrials.gov