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The Influence of Malnutrition, Diabetes Mellitus, and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population

NCT04526613 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 626

Last updated 2026-03-12

No results posted yet for this study

Summary

About 2 billion people worldwide are infected with tuberculosis (TB). Ninety percent of those people have latent TB infection (LTBI). Risk factors like malnutrition, diabetes mellitus (DM), and helminth infection can affect the development of active TB. Researchers want to study LTBI individuals with these issues to see how they may contribute to a person s higher risk for developing active TB. This study will take place in Chennai, India.

Objective:

To estimate the prevalence of malnutrition, DM, and helminth infections in people with LTBI.

Eligibility:

People age 14 65 with or without LTBI.

Design:

Participants will be screened with a medical history and physical exam focused on symptoms of active TB. Those who have TB symptoms will not take part in the study. Those who do not have TB symptoms will have a physical exam with vital signs, height, and weight. They will give blood and stool samples.

Participants will be assigned to 1 of 6 groups. They will repeat some of the screening tests. They will give urine samples. Some groups will have a chest X-ray. Some groups will have an ultrasound of the abdomen.

Participants will complete a survey about their history of smoking and drug and alcohol use.

Participants will have data collected about their nutritional status and body composition. Their skinfold thickness, ratio of waist/hip circumference, and grip strength will be measured.

Participants with DM, malnutrition, or helminth infection will be given standard of care or referred for follow-up treatment.

Participation will last up to 6 months.

...

Conditions

  • Mycobacterium Tuberculosis
  • LTBI (Latent TB Infection)
  • Malnutrition
  • Diabetes Mellitus
  • Helminth Infections

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Thomas B Nutman, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-19
Primary Completion
2026-03-11
Completion
2026-03-11

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04526613 on ClinicalTrials.gov