Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tuberculosis, Pulmonary Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Helminthiasis Infections Lung Diseases Malnutrition Mycobacterium Infections Nutrition Disorders Nutritional and Metabolic Diseases Parasitic Diseases Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India

About this study

LEOPARD Cohort 1-

Control:

Pulmonary TB patients who are newly diagnosed smear-positive (>/=1+ Acid-fast bacillus/AFB) and whose household contacts are enrolled in the TB-LION (Learning Impact of Nutrition) study but are not receiving nutritional supplementation
50 participants will be enrolled and followed for up to 12 months
Stool sample will be collected at the week 1 visit (visit 2)
Blood samples will be collected the screening visit, week 1, month 2, and month 6
Sputum samples will be collected at the screening visit, week 1, week 2, and month 6

TB LION:

Pulmonary TB patients who are newly diagnosed smear-positive (>/=1+ AFB) and whose household contacts are enrolled in the TB-LION study and are receiving nutritional supplementation
50 participants will be enrolled and followed for up to 12 months
Index case and rest of household will receive nutritional supplementation for 6 months
Stool sample will be collected at the week 1 visit (visit 2)
Blood samples will be collected at the screening visit, week 1, month 2, and month 6
Sputum samples will be collected at the screening visit, week 1, week 2, and month 6

LEOPARD Cohort 2-

Pulmonary TB patients who are newly diagnosed smear-positive (>/=1+ AFB) and whose household contacts are not enrolled in the TB-LION study
300 participants will be enrolled and followed for up to 6 months
Stool sample will be collected at the week 1 visit (visit 2)
Blood samples will be collected at the screening visit and week 1
Sputum samples will be collected at the screening visit, week 1, and week 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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)

Treatment and study plan

Primary outcomes

Percent of participants who successfully complete TB treatment

Time frame: 6 months

The number of participants that successfully completed treatment without bacteriological evidence of failure for two continuous weeks will be divided by the number of participants who started TB treatment.
Body Mass Index (BMI) at the end of treatment

Time frame: 6 months

BMI will be calculated as weight/height in kg/m2. The height of participants will be measured by study team members at a home visit . Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect). Body weight will be measured to the nearest 0.1 kg. Low BMIs <18.5 are associated with malnutrition.
Detection of parasites in stool specimen

Time frame: 1 week

Stool specimens collected at the first visit will be tested for intestinal parasites using polymerase chain reaction (PCR).

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Collaborators

Jawaharlal Institute of Postgraduate Medical Education & Research

Registry information

Official study title

Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets (TB-LEOPARD)

Acronym: TB-LEOPARD

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Sep 17, 2021
Registry last updated: Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed