Clinical trialNCT05048485CompletedObservational

Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets

SponsorBoston Medical CenterEnrollment141HelminthiasisMalnutritionTuberculosis, Pulmonary

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Pakrash Babu Narasimhan, PhD
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Principal Investigator
clinicaltrials.gov ↗
Pranay Sinha, MD
Boston Medical Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

2 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

India

Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, India

United States

Boston Medical Center
Boston, Massachusetts, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 9 Apr 2022
Primary completion: 21 Jul 2025
Completion: 21 Jul 2025
Last update posted: 4 Nov 2025
Registered enrollment: 141
Registry id: NCT05048485

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.