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The Impact of Malnutrition on Immune Responses to Tuberculosis

The Impact of Malnutrition on Immune Responses to Tuberculosis in Indian Children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05044910
Acronym
TBMAM
Enrollment
200
Registered
2021-09-16
Start date
2020-08-01
Completion date
2024-12-01
Last updated
2024-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malnutrition, Child, Tuberculosis

Keywords

malnutrition, moderate acute malnutrition, immunology

Brief 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.

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

Interventions

Children with malnutrition will be given RUSF

Sponsors

Institute of Child Health, Madras Medical College, Chennai
CollaboratorUNKNOWN
Stanley Medical College
CollaboratorOTHER_GOV
Kanchi Kamakoti Childs Trust Hospital, Chennai, India
CollaboratorUNKNOWN
Queen Mary University of London
CollaboratorOTHER
London School of Hygiene and Tropical Medicine
CollaboratorOTHER
DBT, India
CollaboratorUNKNOWN
Tuberculosis Research Centre, India
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Months to 60 Months

Inclusion criteria

* 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

Exclusion criteria

* Inclusion criteria not met * 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

Design outcomes

Primary

MeasureTime frameDescription
IFNγ concentration6 monthsIFNγ concentration in supernatant after overnight incubation of whole blood with TB antigens

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026