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

NCT04526613 | Completed

• 2 other identifiers: 99992014420-I-N144
• Study Type: observational
• Target: 626
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MALNUTRITION; Diabetes Mellitus; Helminth Infections; Pathogenesis; Immunological Assays

Outcome Measures

Primary Outcomes (1)

• Prevalence of malnutrition, DM and helminth infections in LTBI individuals and their effects on biosignatures

  Prevalence of malnutrition, DM and helminth infections in LTBI individuals and their effects on biosignatures

  Study Phase visit

Study Arms (6)

'healthy' LTBI+ controls who are negative for all of the conditions

'healthy' LTBI+ controls who are negative for all of the listed conditions

healthy LTBI negative controls with none of the above conditio

healthy LTBI negative controls with none of the above conditions

LTBI+ and helminth infection (positive stool qPCR and/or serol

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

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

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

LTBI+ and uncontrolled DM (HbA1c >8%)

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

LTBI+ with more than one of the conditions defined in groups 1

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

Eligibility Criteria

• Age: 14 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from villages in the Kancheepuram District in south India. The census in villages in the Kancheepuram District is updated annually by local health workers employed by the Department of Public Health and the field teams of the NIRT in Chennai, India. The villages will be chosen in consultation with the Department of Public Health in Tamil Nadu.

You may qualify if:

• 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.

You may not qualify if:

• Pulmonary symptoms suggestive of TB (cough \>2 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis).
• Two IGRA tests with indeterminate results (mitogen values \<10 IU).
• 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.
• Pulmonary symptoms suggestive of TB (cough \>2 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis).
• Pregnant or lactating women.
• Previous treatment for LTBI.
• Anemia with hemoglobin \<8 g/dl (evaluated at the screening phase visit).
• For LTBI+ participants, clinically indicated chest X-ray positive for pulmonary TB.
• For malnourished participants, clinically indicated abdominal ultrasound positive for abdominal TB.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institute for Research In Tuberculosis, International Centers for Exel

Chennai, India

Location

Related Publications (2)

• Barry CE 3rd, Boshoff HI, Dartois V, Dick T, Ehrt S, Flynn J, Schnappinger D, Wilkinson RJ, Young D. The spectrum of latent tuberculosis: rethinking the biology and intervention strategies. Nat Rev Microbiol. 2009 Dec;7(12):845-55. doi: 10.1038/nrmicro2236. Epub 2009 Oct 26.

  PMID: 19855401 BACKGROUND

• Lin PL, Flynn JL. Understanding latent tuberculosis: a moving target. J Immunol. 2010 Jul 1;185(1):15-22. doi: 10.4049/jimmunol.0903856.

  PMID: 20562268 BACKGROUND

MeSH Terms

Conditions

Malnutrition; Diabetes Mellitus; Trematode Infections

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Helminthiasis; Parasitic Diseases; Infections

Study Officials

• Thomas B Nutman, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: August 26, 2020
• Study Start: April 19, 2021
• Primary Completion: March 11, 2026
• Study Completion: March 11, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)