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
The objectives of this research are to determine:
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-
LEOPARD Cohort 2 -
LEOPARD Cohort 1-
Control:
TB LION:
LEOPARD Cohort 2-
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's enrollment of 141 is below the median of 300 across 83 observational studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Boston Medical Center is the lead sponsor of 323 studies on the registry; 33 are open to participants now.
Of its 34 completed or terminated interventional studies of FDA-regulated products, 28 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
The study population is newly diagnosed smear-positive (>/=1+ AFB) pulmonary TB patients living in Puducherry and Tamil Nadu.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Apr 2022 to primary completion in Jul 2025, 39 months.
Of 44 observational studies under Tuberculosis, Pulmonary, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 49. This study's 39 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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