Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Institute of Child Health, Madras Medical College, Chennai | UNKNOWN |
| Stanley Medical College | OTHER_GOV |
| Kanchi Kamakoti Childs Trust Hospital, Chennai, India | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MAM children with TB disease |
| ||
| Wellnourished children with TB disease | |||
| MAM children with latent TB infection |
| ||
| Well-nourished children with latent TB infection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ready to Use supplementary food (RUSF) | Dietary Supplement | Children with malnutrition will be given RUSF |
|
| Measure | Description | Time Frame |
|---|---|---|
| IFNγ concentration | IFNγ concentration in supernatant after overnight incubation of whole blood with TB antigens | 6 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
HIV negative, BCG vaccinated
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Aishwarya Venkataraman, MRCPCH | ICMR-NIRT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Child Health | Chennai | Tamil Nadu | 600 008 | India | ||
| Government Stanley Medical College and Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36252397 | Derived | 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. |
Not provided
Not provided
Data will be shared according to ICMR rules and regulations after appropriate approvals
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| D014376 | Tuberculosis |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
Not provided
Not provided
| Queen Mary University of London |
| OTHER |
| London School of Hygiene and Tropical Medicine | OTHER |
| DBT, India | UNKNOWN |
Not provided
Not provided
Not provided
| Chennai |
| Tamil Nadu |
| 600001 |
| India |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |