Tuberculosis, PulmonaryTB-LEOPARDNCT05048485
Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets
An observational study of Tuberculosis, Pulmonary and Helminthiasis, run by Boston Medical Center at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary, Helminthiasis, Malnutrition
- How many people
- 141 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Apr 2022to 21 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is newly diagnosed smear-positive (>/=1+ AFB) pulmonary TB patients living in Puducherry and Tamil Nadu.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
India1 site
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, 605006
About this study
Official title: Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets (TB-LEOPARD)
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
Read more
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
- Tuberculosis, Pulmonary, Helminthiasis, Malnutrition
- Keywords
- Nutritional supplements, TB LION, India
- Medical subject headings
- Tuberculosis, Pulmonary, Helminthiasis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start9 Apr 2022
- Primary completion21 Jul 2025
- Study completion21 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Jawaharlal Institute of Postgraduate Medical Education & Research
- Responsible party
- Sponsor
- Investigators
- Pranay Sinha, MD, Principal investigator, Boston Medical CenterPakrash Babu Narasimhan, PhD, Principal investigator, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048485
- Sponsor's protocol ID
- H-41912
- Other IDs
- H-41912
- Acronym
- TB-LEOPARD
- Status last verified
- Nov 2025
- First submitted
- 9 Sep 2021
- Last updated
- 4 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets (TB-LEOPARD)
- ClinicalTrials.gov ID
- NCT05048485
- Acronym / sponsor ID
- TB-LEOPARD / H-41912
- Conditions
- Tuberculosis, Pulmonary, Helminthiasis, Malnutrition
- Keywords
- Nutritional supplements, TB LION, India
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Jawaharlal Institute of Postgraduate Medical Education & Research
- Study start
- 9 Apr 2022 (actual)
- Primary completion
- 21 Jul 2025 (actual)
- Study completion
- 21 Jul 2025 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is newly diagnosed smear-positive (>/=1+ AFB) pulmonary TB patients living in Puducherry and Tamil Nadu.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pranay Sinha, MD principal investigator
Boston Medical Center
Pakrash Babu Narasimhan, PhD principal investigator
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary and Helminthiasis, run by Boston Medical Center at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of participants who successfully complete TB treatment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2025.