Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
NCT number |
NCT05048485 |
Other study ID # |
H-41912 |
Secondary ID |
H-41912 |
Status |
Enrolling by invitation |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 9, 2022 |
Est. completion date |
December 2025 |
Study information
Verified date |
April 2024 |
Source |
Boston Medical Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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 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.
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