Severe acute malnutrition (SAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF.
The trial will include SAM children of either sex without any medical complication
Children aged between 6-<24 months and with MUAC <115 mm and/or WLZ <-3
Children are not suffering from SAM.
Children with bi-pedal oedema.
Failed to obtain consent for study participation from parents or legal guardian.
Suffering from any chronic illness(es) or having severe anemia (< 8 g/dl).
Parallel
Microbiota-Directed Food
Dietary supplementMDF is a microbiota directed food for malnourished children aged 6 months and above. It is in sachet form. The sachet contains 92 gm of supplements and provides approximately 506 kcal.
Ready-to-Use Therapeutic Food
Dietary supplementRUTF is standard ready-to-use therapeutic food for SAM children aged 6 months and above.
Mean change in Weight-for-Length Z-score (WLZ)
In this study, nutritional status will be assessed through anthropometric measurement at enrolment, every two weeks interval during the intervention phase and then monthly for the first three months of the follow up period and then at three monthly for the rest of the period until end of the study.
Gut microbial community repair
Non-diarrheal stool samples will be collected at enrolment, monthly during the intervention period, at the end of intervention and at 4, 5, 6, 9, 12th month during the follow-up period and the end of study from all the participants for assessment of the composition of gut microbiota and features of the microbiome. Oral swab samples will be collected by using a commercial kit from each child at enrolment, after the intervention/treatment, and at the end of the follow-up period for measuring microbiota.
Improvement in the levels of plasma protein biomarkers of healthy growth
Blood samples will be collected at enrolment and just after the intervention is completed and at the 9th month during follow up period and at the end of the study. Non-diarrheal stool samples will be collected at enrolment, monthly during the intervention period, at the end of intervention and at 4, 5, 6, 9, 12th month during the follow-up period and the end of study from all the participants for measuring biomarkers of gut inflammation.
Mean change in Weight-for-Age Z-score (WAZ)
In this study, nutritional status will be assessed through anthropometric measurement at enrolment, every two weeks interval during the intervention phase and then monthly for the first three months of the follow up period and then at three monthly for the rest of the period until end of the study.
Mean change in Length-for-Age Z-score (LAZ)
In this study, nutritional status will be assessed through anthropometric measurement at enrolment, every two weeks interval during the intervention phase and then monthly for the first three months of the follow up period and then at three monthly for the rest of the period until end of the study.
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International Centre for Diarrhoeal Disease Research, Bangladesh
Lead sponsor
Washington University School of Medicine
Collaborator
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