Status:
ACTIVE_NOT_RECRUITING
The Influence of Malnutrition, Diabetes Mellitus, and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Mycobacterium Tuberculosis
LTBI (Latent TB Infection)
Eligibility:
All Genders
14-65 years
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 helmin...
Detailed Description
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...
Eligibility Criteria
Inclusion
- PARTICIPANT INCLUSION CRITERIA (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.
- PARTICIPANT EXCLUSION CRITERIA (Screening Phase)
- 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).
- PARTICIPANT INCLUSION CRITERIA (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.
- PARTICIPANT EXCLUSION CRITERIA (Study Phase)
- 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.
- Known documented cases of cancer, acquired immune deficiency syndrome, or other immunosuppressive illness.
- 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.
Exclusion
Key Trial Info
Start Date :
April 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2026
Estimated Enrollment :
626 Patients enrolled
Trial Details
Trial ID
NCT04526613
Start Date
April 19 2021
End Date
June 25 2026
Last Update
July 11 2025
Active Locations (1)
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1
National Institute for Research In Tuberculosis, International Centers for Exel
Chennai, India