Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets

NCT05048485 | Completed

• 1 other identifier: H-41912
• Study Type: observational
• Target: 141
• Locations: 2 countries
• Sites: 2

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.

Conditions

Tuberculosis, Pulmonary; Helminthiasis; Malnutrition

Keywords

Nutritional supplements; TB LION; India

Outcome Measures

Primary Outcomes (3)

• Percent of participants who successfully complete TB treatment

  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.

  6 months

• Body Mass Index (BMI) at the end of treatment

  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.

  6 months

• Detection of parasites in stool specimen

  Stool specimens collected at the first visit will be tested for intestinal parasites using polymerase chain reaction (PCR).

  1 week

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Medical Center: lead
• Jawaharlal Institute of Postgraduate Medical Education & Research: collaborator

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, 605006, India

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, sputum and stool samples will be collected and some samples will be retained for future testing. The PaxGene tubes will be collected and stored for future analysis to study RNA sequences for transcriptional differences between persons with TB with and without intestinal infections. Plasma samples and analysis of analytes will be analyzed to investigate further the immunologic mechanisms and to assess how these responses are modulated over time by treatment of parasites and by feeding individuals. Serum samples will be retained for future analysis of micronutrients and assessment of the immune response. Stool samples will be frozen for future microbiome analysis. Sputum samples obtained for the study will be assessed for differentially culturable TB variants.

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Helminthiasis; Malnutrition

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Parasitic Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Pranay Sinha, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

• Pakrash Babu Narasimhan, PhD

  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 17, 2021
• Study Start: April 9, 2022
• Primary Completion: July 21, 2025
• Study Completion: July 21, 2025
• Last Updated: November 4, 2025

Record last verified: 2025-11

Locations

IN (1); US (1)