Clinical trial NCT05048485: Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets
Official title: Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets (TB-LEOPARD)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Tuberculosis, Pulmonary
Helminthiasis
Malnutrition
Keywords: Nutritional supplements
TB LION
India
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: Jawaharlal Institute of Postgraduate Medical Education & Research
First posted: 2021-09-17
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is newly diagnosed smear-positive (\>/=1+ AFB) pulmonary TB patients living in Puducherry and Tamil Nadu.

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

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

Eligibility criteria: 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)

Primary outcomes:
measure: Percent of participants who successfully complete TB treatment
timeFrame: 6 months
measure: Body Mass Index (BMI) at the end of treatment
timeFrame: 6 months
measure: Detection of parasites in stool specimen
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Puducherry
country: India
facility: Jawaharlal Institute of Postgraduate Medical Education and Research
Study officials:
affiliation: Boston Medical Center
name: Pranay Sinha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
name: Pakrash Babu Narasimhan, PhD
role: PRINCIPAL_INVESTIGATOR
References: