Malnutrition, ChildTBMAMNCT05044910
The Impact of Malnutrition on Immune Responses to Tuberculosis
An observational study of Malnutrition, Child and Tuberculosis, run by Tuberculosis Research Centre, India at 2 sites in India.
Trial summary
The aim of this study is to assess immune responses to Mtb in children with MAM compared to well-nourished children and to evaluate the impact of a nutrition intervention on these immune responses. Read more about this study
- Who is it for?
- Ages 12 to 60 months
- Conditions the study is for
- Malnutrition, Child, Tuberculosis
- What is being tested?
- Ready to Use supplementary food (RUSF)
- How many people
- 200 participants
- Where
- 2 sitesIndia
- Study dates
- 1 Aug 2020to 1 Dec 2024
- 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 12 to 60 months
- All sexes
- Child
Study population: HIV negative, BCG vaccinated
Who may be able to join
- Age 12-60 months
- HIV-negative
- BCG vaccinated
- Moderate acute malnutrition (WHZ -2 to -3 or MUAC 115 - 125mm ± HAZ <-2)
- TB disease
- Latent TB infection
Show all 13Show fewer
- Severe acute malnutrition (WHZ<-3; MUAC<115mm; bilateral oedema)
- Severe anaemia (Hb: <7g/dl)
- Chronic infection (HIV, hepatitis B or C)
- Chronic disease (e.g. Crohn's disease)
- Feeding problems (eg cerebral palsy) that prevent ingestion of RUSF
- Known nut allergy
- MDR TB disease and contacts of MDR TB adults
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Institute of Child Health
Chennai, Tamil Nadu, 600 008
Government Stanley Medical College and Hospital
Chennai, Tamil Nadu, 600001
About this study
Official title: The Impact of Malnutrition on Immune Responses to Tuberculosis in Indian Children
The aim of this study is to assess immune responses to Mtb in children with MAM compared to well-nourished children and to evaluate the impact of a nutrition intervention on these immune responses.
Read the detailed description
Immune dysfunction in malnourished children is poorly characterised. The aim of this study is to assess immune responses to Mycobacterium tuberculosis (Mtb) in children with moderate acute malnutrition (MAM) compared to wellnourished children and to evaluate the impact of a nutrition intervention on these immune responses. Innate and adaptive immune responses to Mtb will be characterised in four groups: 1) MAM children with TB disease; 2) Wellnourished children with TB disease; 3) MAM children with latent TB infection; 4) Well-nourished children with latent TB infection. A range of assays to compare innate, adaptive and functional immune responses to TB between groups will be performed. Whether nutritional supplementation improves immune function in MAM children remains uncertain. Hence, children in all four groups will be followed up during 6 months of TB therapy/chemoprophylaxis. MAM children will receive 12 weeks of concomitant ready-to-use supplementary food, to evaluate longitudinal changes in innate and adaptive immune function, monocyte:lymphocyte ratio and mycobacterial growth inhibition. The results of this study will provide data to understand the reasons for infection susceptibility in malnourished children and provide a proof-of-concept that nutritional rehabilitation promotes immune rehabilitation. It will also provide a proof-of concept for use of nutritional supplementation as adjust therapy in TB disease
- Conditions
- Malnutrition, Child, Tuberculosis
- Being tested
- Ready to Use supplementary food (RUSF)
- Keywords
- malnutrition, moderate acute malnutrition, immunology
- Medical subject headings
- Child Nutrition Disorders, Tuberculosis, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ready to Use supplementary food (RUSF)Dietary supplement
Children with malnutrition will be given RUSF
| Study group | Role | What they receive |
|---|---|---|
| MAM children with TB disease | Not described Receives: Dietary Supplement: Ready to Use supplementary food (RUSF) | |
| Wellnourished children with TB disease | Not described | |
| MAM children with latent TB infection | Not described Receives: Dietary Supplement: Ready to Use supplementary food (RUSF) | |
| Well-nourished children with latent TB infection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
IFNγ concentration
IFNγ concentration in supernatant after overnight incubation of whole blood with TB antigens
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start1 Aug 2020
- Primary completion31 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malnutrition, ChildStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tuberculosis Research Centre, India
- Sponsor type
- Other government
- Collaborators
- Institute of Child Health, Madras Medical College, Chennai, Stanley Medical College, Kanchi Kamakoti Childs Trust Hospital, Chennai, India, Queen Mary University of London, London School of Hygiene and Tropical Medicine, DBT, India
- Responsible party
- Sponsor
- Investigators
- Aishwarya Venkataraman, MRCPCH, Principal investigator, ICMR-NIRT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044910
- Sponsor's protocol ID
- 2019037
- Acronym
- TBMAM
- Status last verified
- May 2024
- First submitted
- 9 Sep 2021
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared according to ICMR rules and regulations after appropriate approvals
Publications
Venkataraman A, Shanmugam S, Balaji S, Mani K, Shanmugavel AK, Muthuramalingam K, Hissar S, Thiruvengadam K, Selladurai E, Smuk M, Hanna LE, Prendergast AJ. Comparison of two mycobacterial strains in performance of the whole blood mycobacterial growth inhibition assay in Indian children. Tuberculosis (Edinb). 2022 Dec;137:102255. doi: 10.1016/j.tube.2022.102255. Epub 2022 Aug 31.
PubMed 36252397
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Malnutrition on Immune Responses to Tuberculosis in Indian Children
- ClinicalTrials.gov ID
- NCT05044910
- Acronym / sponsor ID
- TBMAM / 2019037
- Conditions
- Malnutrition, Child, Tuberculosis
- Keywords
- malnutrition, moderate acute malnutrition, immunology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tuberculosis Research Centre, IndiaOther government
- Collaborators
- Institute of Child Health, Madras Medical College, Chennai, Stanley Medical College, Kanchi Kamakoti Childs Trust Hospital, Chennai, India, Queen Mary University of London, London School of Hygiene and Tropical Medicine, DBT, India
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 16 Sep 2021 (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.
The aim of this study is to assess immune responses to Mtb in children with MAM compared to well-nourished children and to evaluate the impact of a nutrition intervention on these immune responses.
Detailed description
Immune dysfunction in malnourished children is poorly characterised. The aim of this study is to assess immune responses to Mycobacterium tuberculosis (Mtb) in children with moderate acute malnutrition (MAM) compared to wellnourished children and to evaluate the impact of a nutrition intervention on these immune responses. Innate and adaptive immune responses to Mtb will be characterised in four groups: 1) MAM children with TB disease; 2) Wellnourished children with TB disease; 3) MAM children with latent TB infection; 4) Well-nourished children with latent TB infection. A range of assays to compare innate, adaptive and functional immune responses to TB between groups will be performed. Whether nutritional supplementation improves immune function in MAM children remains uncertain. Hence, children in all four groups will be followed up during 6 months of TB therapy/chemoprophylaxis. MAM children will receive 12 weeks of concomitant ready-to-use supplementary food, to evaluate longitudinal changes in innate and adaptive immune function, monocyte:lymphocyte ratio and mycobacterial growth inhibition. The results of this study will provide data to understand the reasons for infection susceptibility in malnourished children and provide a proof-of-concept that nutritional rehabilitation promotes immune rehabilitation. It will also provide a proof-of concept for use of nutritional supplementation as adjust therapy in TB disease
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MAM children with TB disease | – | Dietary Supplement: Ready to Use supplementary food (RUSF) |
| Wellnourished children with TB disease | – | – |
| MAM children with latent TB infection | – | Dietary Supplement: Ready to Use supplementary food (RUSF) |
| Well-nourished children with latent TB infection | – | – |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- All
- Age groups
- Child
- Study population
- HIV negative, BCG vaccinated
Key inclusion criteria (13 listed)
- Age 12-60 months
- HIV-negative
- BCG vaccinated
- Moderate acute malnutrition (WHZ -2 to -3 or MUAC 115 - 125mm ± HAZ <-2)
- TB disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ready to Use supplementary food (RUSF)Children with malnutrition will be given RUSF | Dietary supplement | MAM children with TB disease, MAM children with latent TB infection |
Primary outcome
IFNγ concentration
Time frame: 6 months
IFNγ concentration in supernatant after overnight incubation of whole blood with TB antigens
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 36252397Venkataraman A, Shanmugam S, Balaji S, Mani K, Shanmugavel AK, Muthuramalingam K, Hissar S, Thiruvengadam K, Selladurai E, Smuk M, Hanna LE, Prendergast AJ. Comparison of two mycobacterial strains in performance of the whole blood mycobacterial growth inhibition assay in Indian children. Tuberculosis (Edinb). 2022 Dec;137:102255. doi: 10.1016/j.tube.2022.102255. Epub 2022 Aug 31.
- Individual participant dataSharing planned: No. Data will be shared according to ICMR rules and regulations after appropriate approvals
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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.
Aishwarya Venkataraman, MRCPCH principal investigator
ICMR-NIRT
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, Child and Tuberculosis, run by Tuberculosis Research Centre, India at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
IFNγ concentration (time frame: 6 months). 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 NCT05044910, which also lists 1 linked publication.
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 29 May 2024.