CompletedNCT05048485TB-LEOPARDUpdated Nov 4, 2025

Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets

An observational study in Tuberculosis, Pulmonary, Helminthiasis and Malnutrition, sponsored by Boston Medical Center. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-04.

Sponsored by Boston Medical Center · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 141
Ages: 18 Years and older
Sex: All

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.

Read the detailed description

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

Conditions studied

Tuberculosis, Pulmonary
Helminthiasis
Malnutrition

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Keywords

Nutritional supplements
TB LION
India

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

The study population is newly diagnosed smear-positive (>/=1+ AFB) pulmonary TB patients living in Puducherry and Tamil Nadu.

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

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)

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 141 participants (actual)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

LEOPARD Cohort 1
Control group: The study will enroll 50 newly diagnosed smear-positive (\>/=1+ AFB) pulmonary TB patients whose household contacts are enrolled in the TB-LION study and who are not receiving nutritional supplementation. TB LION group: The study will enroll 50 newly diagnosed smear-positive (\>/=1+ AFB) pulmonary TB patients whose household contacts are enrolled in the TB-LION study and who are receiving nutritional supplementation.
LEOPARD Cohort 2
The study will enroll 300 newly diagnosed smear-positive (\>/=1+ AFB) pulmonary TB patients whose household contacts are not enrolled in the TB-LION study.

What researchers measure

Primary outcomes

Percent of participants who successfully complete TB treatment
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.
Time frame: 6 months
Body Mass Index (BMI) at the end of treatment
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.
Time frame: 6 months
Detection of parasites in stool specimen
Stool specimens collected at the first visit will be tested for intestinal parasites using polymerase chain reaction (PCR).
Time frame: 1 week

Study locations

2 sites

Boston Medical Center
Boston, Massachusetts 02118, United States
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, 605006, India

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT05048485
Lead sponsor: Boston Medical Center
Collaborators: Jawaharlal Institute of Postgraduate Medical Education & Research
Responsible party: Sponsor
First posted: Sep 17, 2021
Start date: Apr 9, 2022
Primary completion: Jul 21, 2025
Completion: Jul 21, 2025
Last update: Nov 4, 2025

Study contacts

Pranay Sinha, MD

principal investigator · Boston Medical Center

Pakrash Babu Narasimhan, PhD

principal investigator · Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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