Investigating Comorbidities in Latent Tuberculosis

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

This study is trying to find out if people aged 14 to 65 with latent tuberculosis also have other health issues like diabetes or malnutrition.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 14 Years to 65 Years
• Sex: All
• Sponsor: Tuberculosis Research Centre, India (Government)
• Locations: 1 site (Chennai, Tamilnadu)
• Trial ID: NCT04642755 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify individuals with latent tuberculosis infection (LTBI) and associated comorbidities such as malnutrition, diabetes mellitus, and helminth infections. Participants aged 14 to 65 will be screened for LTBI using interferon gamma release assays and assessed for their comorbid conditions. Those who are asymptomatic for active TB will be categorized into groups based on their LTBI status and presence of comorbidities. The study will involve clinical assessments and collection of biological samples for further research on immune responses.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 14 to 65 with latent tuberculosis and specific comorbidities such as malnutrition, uncontrolled diabetes, or helminth infections.

Not a fit: Patients with active tuberculosis symptoms or those outside the age range of 14 to 65 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of how comorbidities affect the management and progression of latent tuberculosis, potentially leading to improved treatment strategies.

How similar studies have performed: While studies have explored the relationship between TB and HIV extensively, this approach focusing on other comorbidities in low-HIV-endemic regions is relatively novel.

Eligibility criteria

Inclusion Criteria:

Screening Phase:

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

1. Aged 14 to 65 years.
2. Willingness to provide blood, urine, and stool samples for examination.
3. Willingness to have samples and data stored.
4. 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:

1. LTBI+ and severe to moderate malnutrition (BMI \<17 kg/m2);
2. LTBI+ and uncontrolled DM (HbA1c \>8%);
3. LTBI+ and helminth infection (positive stool qPCR and/or serology);
4. LTBI+ with more than one of the conditions defined in groups 1-3;
5. "healthy" LTBI+ controls who are negative for all of the above conditions; and
6. healthy LTBI negative controls with none of the above conditions.

Exclusion Criteria:

Screening Phase:

1. Pulmonary symptoms suggestive of TB (cough \>2 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis).
2. Two IGRA tests with indeterminate results (mitogen values \<10 IU).

Study Phase:

1. Pulmonary symptoms suggestive of TB (cough \>2 weeks in duration and/or intermittent fever \>1 week in duration and/or hemoptysis).
2. Pregnant or lactating women.
3. Previous treatment for LTBI.
4. Anemia with hemoglobin \<8 g/dl (evaluated at the screening phase visit).
5. For LTBI+ participants, clinically indicated chest X-ray positive for pulmonary TB.
6. For malnourished participants, clinically indicated abdominal ultrasound positive for abdominal TB.
7. Known documented cases of cancer, acquired immune deficiency syndrome, or other immunosuppressive illness.
8. History of any other illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the participant's participation in the protocol, or compromise the scientific objectives.

Where this trial is running

Chennai, Tamilnadu

• National Institute for Research in Tuberculosis — Chennai, Tamilnadu, India (Recruiting)

Study contacts

• Principal investigator: Subash Babu, MBBS, PhD — National Institute for Research in Tuberculosis
• Study coordinator: Subash Babu, MBBS, PhD

Conditions Latent Tuberculosis; Diabete Mellitus; Malnutrition; Helminth Infection