Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets

NCT ID: NCT05048485

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 141 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-09
• Study Completion Date: 2025-07-21

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

Conditions

Malnutrition; Tuberculosis, Pulmonary; Helminthiasis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jawaharlal Institute of Postgraduate Medical Education & Research

OTHER_GOV

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pranay Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Pakrash Babu Narasimhan, PhD

Role: PRINCIPAL_INVESTIGATOR

Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

Locations

Boston Medical Center

Boston, Massachusetts, United States

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, , India

Countries

United States; India

Other Identifiers

H-41912

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-41912

Identifier Type: -

Identifier Source: org_study_id