TB-LEOPARD: Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets

Sponsor

Boston Medical Center (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05048485

Collaborator

Jawaharlal Institute of Postgraduate Medical Education & Research (Other)

400

Enrollment

Locations

17.7

Anticipated Duration (Months)

200

Patients Per Site

11.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis, Pulmonary Helminthiasis Malnutrition

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets (TB-LEOPARD)

Actual Study Start Date :

Apr 9, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
LEOPARD Cohort 1 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.
LEOPARD Cohort 2 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.

Arm

Intervention/Treatment

LEOPARD Cohort 1

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.

LEOPARD Cohort 2

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.

Outcome Measures

Primary Outcome Measures

Percent of participants who successfully complete TB treatment [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 [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 [1 week]
Stool specimens collected at the first visit will be tested for intestinal parasites using polymerase chain reaction (PCR).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118
2	Jawaharlal Institute of Postgraduate Medical Education and Research	Puducherry		India	605006

Sponsors and Collaborators

Boston Medical Center
Jawaharlal Institute of Postgraduate Medical Education & Research

Investigators

Principal Investigator: Pranay Sinha, MD, Boston Medical Center
Principal Investigator: Pakrash Babu Narasimhan, PhD, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)