A Cross-sectional Study to Estimate the Influence of Malnutrition, Diabetes Mellitus and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Approximately 2 billion people worldwide are infected with Mycobacterium tuberculosis (TB), with 90% of individuals having latent infection (LTBI). The control of TB requires clearly delineated helper T cell (Th) 1 responses and, to a lesser extent, Th17 responses, which both play important roles in the induction and maintenance of protective immune responses in mouse models of TB infection and in the prevention of active disease, as seen in LTBI. During latency, M. tuberculosis is contained in localized granulomas. Mycobacteria specific T cells mediate delayed type hypersensitivity reactions to purified protein derivative (PPD), and this reaction is generally considered to indicate an LTBI status in the absence of demonstrable active infection. Among the various risk factors that are known to play a role in promoting active TB, HIV is the most well studied and described. However, in low-HIV-endemic countries like India, other risk factors might play a more prominent role in active TB pathogenesis. These include malnutrition, diabetes mellitus (DM), and helminth infections. LTBI individuals with these comorbidities or coinfections could be at a higher risk for developing active TB than their healthy LTBI counterparts without these comorbidities. Thus, it is imperative to study the pathogenesis of TB infection and disease in these at risk populations. In this study, we will estimate the prevalence of severe to moderate malnutrition, uncontrolled DM, and helminth infections in LTBI-positive individuals. We will collect samples from a cohort of individuals with LTBI, those with LTBI and coexistent malnutrition, DM, or helminth coinfection, and those without any of these conditions. Individual participation may last up to 6 months. The main objective of the study is to estimate the prevalence of malnutrition, DM, and helminth infections in LTBI individuals. Simultaneously, we will perform transcriptomic, proteomic, and metabolomic assays, including profiles in serum and urine, to determine the biosignature portfolio of these individuals. In addition, immunological assays examining cytokine/chemokine signatures as well as other immune parameters related to innate and adaptive responses will be performed to enhance the understanding of the immunological cross talk between LTBI and malnutrition, DM, and helminth infections.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 65
View:

⁃ Screening Phase:

⁃ Individuals who meet the following criteria are eligible to participate in the screening phase:

• Aged 14 to 65 years.

• Willingness to provide blood, urine, and stool samples for examination.

• Willingness to have samples and data stored.

• Able to provide informed consent.

⁃ Study Phase:

⁃ Individuals are eligible for the study phase if they meet the requirements for one of the study groups, as follows:

• LTBI+ and severe to moderate malnutrition (BMI \<17 kg/m2);

• LTBI+ and uncontrolled DM (HbA1c \>8%);

• LTBI+ and helminth infection (positive stool qPCR and/or serology);

• LTBI+ with more than one of the conditions defined in groups 1-3;

• healthy LTBI+ controls who are negative for all of the above conditions; and

• healthy LTBI negative controls with none of the above conditions.

Locations
Other Locations
India
National Institute for Research in Tuberculosis
RECRUITING
Chennai
Contact Information
Primary
Subash Babu, MBBS, PhD
sbabu@icerindia.org
044-28369711
Backup
Pradeep Menon, MBBS,DPM,MPH
menonpa@nirt.res.in
9444294262
Time Frame
Start Date: 2021-04-19
Estimated Completion Date: 2026-03
Participants
Target number of participants: 300
Treatments
Group 1
LTBI+ and severe to moderate malnutrition
Group 2
LTBI+ and uncontrolled DM
Group 3
LTBI+ and helminth infection
Group 4
LTBI+ with more than one of the above conditions (severe to moderate malnutrition, DM, helminth infection)
Group 5
Healthy LTBI+ controls who are negative for all of the above conditions (severe to moderate malnutrition, DM, helminth infection)
Group 6
Healthy LTBI negative controls with none of the above conditions (severe to moderate malnutrition, DM, helminth infection).
Related Therapeutic Areas
Sponsors
Collaborators: National Institutes of Health (NIH)
Leads: Tuberculosis Research Centre, India

This content was sourced from clinicaltrials.gov