NCT05048485Completed
Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets
Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets (TB-LEOPARD)
Source: ClinicalTrials.gov · Last updated 4 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 141 (actual)
- First submitted
- 9 Sept 2021
- Start date
- 9 Apr 2022
- Primary completion date
- 21 Jul 2025
- Lead sponsor
- Boston Medical Center
- Diseases
- Tuberculosis
- NCT number
- NCT05048485
What you commit to
- Study type: Observational
- Participants enrolled: 141
- From 9 Apr 2022 to the primary completion date, 21 Jul 2025
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known multidrug-resistant tuberculosis (MDR) or extensively drug resistant (XDR) TB case at recruitment or found at time of enrollment
Lab values
- Previously diagnosed with diabetes or hemoglobin A1c\>6.5% on testing
Other
- Household contact ineligible for TB LION study
- Pregnant at enrollment
- No Xpert or culture confirmation and unable to provide sputum sample
- BMI \<14 kg/m2
- Lower extremity edema/kwashiorkor
- Reported neuropathy in lower extremities (may result from thiamine deficiency)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jawaharlal Institute of postgraduate medical education and research Coordinator of this site? Confirm its status | Puducherry | India | Unknown status |
| Boston Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.