NCT04526613Completed
The Influence of Malnutrition, Diabetes Mellitus, and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population
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
Source: ClinicalTrials.gov · Last updated 12 Mar 2026
Brief summary (registry, in English)
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. ...
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 626 (actual)
- First submitted
- 25 Aug 2020
- Start date
- 19 Apr 2021
- Primary completion date
- 11 Mar 2026
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Diseases
- Tuberculosis
- NCT number
- NCT04526613
What you commit to
- Study type: Observational
- Participants enrolled: 626
- From 19 Apr 2021 to the primary completion date, 11 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 14 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute for Research In Tuberculosis, International Centers for Exel Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.