Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets (TB-LEOPARD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Medical Center
- Enrollment
- 141
- Locations
- 2
- Primary Endpoint
- Percent of participants who successfully complete TB treatment
Study Overview
Brief 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.
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
No secondary outcomes reported