Tuberculosis - Learning the Effect of Parasites and Reinforcing Diets

Malnutrition Clinical Trial

— TB-LEOPARD  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05048485
• Other study ID #: H-41912
• Secondary ID: H-41912
• Status: Enrolling by invitation
• Start date: April 9, 2022
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Helminthiasis
• Malnutrition
• Tuberculosis
• Tuberculosis, Pulmonary

Locations

Country	Name	City	State
India	Jawaharlal Institute of Postgraduate Medical Education and Research	Puducherry
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston Medical Center	Jawaharlal Institute of Postgraduate Medical Education & Research

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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