Mycobacterium TuberculosisNCT04526613
The Influence of Malnutrition, Diabetes Mellitus, and Helminth Infections on Biosignatures in Latent Tuberculosis in a South Indian Population
An observational study of Mycobacterium Tuberculosis and LTBI (Latent TB Infection), run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mycobacterium Tuberculosis, LTBI (Latent TB Infection), Malnutrition
- How many people
- 626 participants
- Where
- 1 siteIndia
- Study dates
- 19 Apr 2021to 11 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
National Institute for Research In Tuberculosis, International Centers for Exel
Chennai
About this study
Official title: 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
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:
Read more
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.
...
Read the 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 T cell (Th) 1 responses and, to a lesser extent, Th17 responses, which both play important roles in the induction and maintenance of protective immune responses in mouse models of TB infection and in the prevention of active disease, as seen in LTBI. During latency, M. tuberculosis is contained in localized granulomas. Mycobacteria-specific T cells mediate delayed-type hypersensitivity reactions to purified protein derivative (PPD), and this reaction is generally considered to indicate an LTBI status in the absence of demonstrable active infection.
Among the various risk factors that are known to play a role in promoting active TB, HIV is the most well studied and described. However, in low-HIV-endemic countries like India, other risk factors might play a more prominent role in active TB pathogenesis. These include malnutrition, diabetes mellitus (DM), and helminth infections. LTBI individuals with these comorbidities or coinfections could be at a higher risk for developing active TB than their healthy LTBI counterparts without these comorbidities. Thus, it is imperative to study the pathogenesis of TB infection and disease in these at-risk populations.
In this study, we will estimate the prevalence of severe to moderate malnutrition, uncontrolled DM, and helminth infections in LTBI-positive individuals. We will collect samples from a cohort of individuals with LTBI, those with LTBI and coexistent malnutrition, DM, or helminth coinfection, and those without any of these conditions. Individual participation may last up to 6 months. The main objective of the study is to estimate the prevalence of malnutrition, DM, and helminth infections in LTBI individuals.
Simultaneously, we will perform transcriptomic, proteomic, and metabolomic assays, including profiles in serum and urine, to determine the biosignature portfolio of these individuals. In addition, immunological assays examining cytokine/chemokine signatures as well as other immune parameters related to innate and adaptive responses will be performed to enhance the understanding of the immunological cross-talk between LTBI and malnutrition, DM, and helminth infections.
- Conditions
- Mycobacterium Tuberculosis, LTBI (Latent TB Infection), Malnutrition, Diabetes Mellitus, Helminth Infections
- Keywords
- MALNUTRITION, Diabetes Mellitus, Helminth Infections, Pathogenesis, Immunological Assays
- Medical subject headings
- Malnutrition, Diabetes Mellitus, Trematode Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| '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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Study Phase visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start19 Apr 2021
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mycobacterium TuberculosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Thomas B Nutman, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526613
- Sponsor's protocol ID
- 999920144
- Other IDs
- 20-I-N144
- Status last verified
- Mar 2026
- First submitted
- 25 Aug 2020
- Last updated
- 12 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a sample/data collection study to estimate the prevalence of malnutrition. DM and helminth infections in LBTI subjects. There is no plan to share individual participant data
Publications
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.
PubMed 19855401Lin PL, Flynn JL. Understanding latent tuberculosis: a moving target. J Immunol. 2010 Jul 1;185(1):15-22. doi: 10.4049/jimmunol.0903856.
PubMed 20562268Dasan B, Rajamanickam A, Pandiarajan AN, Shanmugam S, Nott S, Babu S. Immunological mechanisms of tuberculosis susceptibility in TB-infected individuals with type 2 diabetes mellitus: insights from mycobacterial growth inhibition assay and cytokine analysis. Microbiol Spectr. 2025 Jan 7;13(1):e0144524. doi: 10.1128/spectrum.01445-24. Epub 2024 Dec 10.
PubMed 39656000
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04526613
- Acronym / sponsor ID
- 999920144
- Conditions
- Mycobacterium Tuberculosis, LTBI (Latent TB Infection), Malnutrition, Diabetes Mellitus, Helminth Infections
- Keywords
- MALNUTRITION, Diabetes Mellitus, Helminth Infections, Pathogenesis, Immunological Assays
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 626 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
...
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 T cell (Th) 1 responses and, to a lesser extent, Th17 responses, which both play important roles in the induction and maintenance of protective immune responses in mouse models of TB infection and in the prevention of active disease, as seen in LTBI. During latency, M. tuberculosis is contained in localized granulomas. Mycobacteria-specific T cells mediate delayed-type hypersensitivity reactions to purified protein derivative (PPD), and this reaction is generally considered to indicate an LTBI status in the absence of demonstrable active infection.
Among the various risk factors that are known to play a role in promoting active TB, HIV is the most well studied and described. However, in low-HIV-endemic countries like India, other risk factors might play a more prominent role in active TB pathogenesis. These include malnutrition, diabetes mellitus (DM), and helminth infections. LTBI individuals with these comorbidities or coinfections could be at a higher risk for developing active TB than their healthy LTBI counterparts without these comorbidities. Thus, it is imperative to study the pathogenesis of TB infection and disease in these at-risk populations.
In this study, we will estimate the prevalence of severe to moderate malnutrition, uncontrolled DM, and helminth infections in LTBI-positive individuals. We will collect samples from a cohort of individuals with LTBI, those with LTBI and coexistent malnutrition, DM, or helminth coinfection, and those without any of these conditions. Individual participation may last up to 6 months. The main objective of the study is to estimate the prevalence of malnutrition, DM, and helminth infections in LTBI individuals.
Simultaneously, we will perform transcriptomic, proteomic, and metabolomic assays, including profiles in serum and urine, to determine the biosignature portfolio of these individuals. In addition, immunological assays examining cytokine/chemokine signatures as well as other immune parameters related to innate and adaptive responses will be performed to enhance the understanding of the immunological cross-talk between LTBI and malnutrition, DM, and helminth infections.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| '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 |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of malnutrition, DM and helminth infections in LTBI individuals and their effects on biosignatures
Time frame: Study Phase visit
Prevalence of malnutrition, DM and helminth infections in LTBI individuals and their effects on biosignatures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Background: PubMed 19855401Barry 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.
- Background: PubMed 20562268Lin PL, Flynn JL. Understanding latent tuberculosis: a moving target. J Immunol. 2010 Jul 1;185(1):15-22. doi: 10.4049/jimmunol.0903856.
- Derived from this study: PubMed 39656000Dasan B, Rajamanickam A, Pandiarajan AN, Shanmugam S, Nott S, Babu S. Immunological mechanisms of tuberculosis susceptibility in TB-infected individuals with type 2 diabetes mellitus: insights from mycobacterial growth inhibition assay and cytokine analysis. Microbiol Spectr. 2025 Jan 7;13(1):e0144524. doi: 10.1128/spectrum.01445-24. Epub 2024 Dec 10.
- Individual participant dataSharing planned: No. This is a sample/data collection study to estimate the prevalence of malnutrition. DM and helminth infections in LBTI subjects. There is no plan to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas B Nutman, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycobacterium Tuberculosis and LTBI (Latent TB Infection), run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of malnutrition, DM and helminth infections in LTBI individuals and their effects on biosignatures (time frame: Study Phase visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04526613, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.