The Impact of Malnutrition on Immune Responses to Tuberculosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2024-12-01

Brief Summary

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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.

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Detailed Description

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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

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Malnutrition, Child Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MAM children with TB disease

Ready to Use supplementary food (RUSF)

Intervention Type DIETARY_SUPPLEMENT

Children with malnutrition will be given RUSF

Wellnourished children with TB disease

No interventions assigned to this group

MAM children with latent TB infection

Ready to Use supplementary food (RUSF)

Intervention Type DIETARY_SUPPLEMENT

Children with malnutrition will be given RUSF

Well-nourished children with latent TB infection

No interventions assigned to this group

Interventions

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Ready to Use supplementary food (RUSF)

Children with malnutrition will be given RUSF

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

* 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

Minimum Eligible Age

12 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No