The Impact of Malnutrition on Immune Responses to Tuberculosis

Tuberculosis Clinical Trial

— TBMAM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05044910
• Other study ID #: 2019037
• Status: Active, not recruiting
• Start date: August 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Tuberculosis Research Centre, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 1, 2024
• Est. primary completion date: August 31, 2024
• Gender: All
• Age group: 12 Months to 60 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child
• Tuberculosis

Intervention

Dietary Supplement:
• Ready to Use supplementary food (RUSF)
Children with malnutrition will be given RUSF

Locations

Country	Name	City	State
India	Government Stanley Medical College and Hospital	Chennai	Tamil Nadu
India	Institute of Child Health	Chennai	Tamil Nadu

Sponsors (7)

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

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IFN? concentration	IFN? concentration in supernatant after overnight incubation of whole blood with TB antigens	6 months