Microbiota Directed Food for Children With Severe Acute Malnutrition

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-24
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Microbiota-Directed Food
  • Ready-to-Use Therapeutic Food

Treatment groups

256 Participants
are divided into 2 treatment groups

Sponsors and collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

Lead sponsor

Washington University School of Medicine

Collaborator