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NOT YET RECRUITING
NCT06308848
NA

Microbiota Directed Food for Children With Severe Acute Malnutrition

Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

View on ClinicalTrials.gov

Summary

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.

Official title: Proof-of-Concept Study for a Microbiota-Directed Food in Children With Uncomplicated Severe Acute Malnutrition in Rural Bangladesh

Key Details

Gender

All

Age Range

6 Months - 24 Months

Study Type

INTERVENTIONAL

Enrollment

256

Start Date

2024-04-15

Completion Date

2026-12-31

Last Updated

2024-03-13

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Microbiota-Directed Food

MDF 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.

DIETARY_SUPPLEMENT

Ready-to-Use Therapeutic Food

RUTF is standard ready-to-use therapeutic food for SAM children aged 6 months and above.

Locations (1)

Kurigram Study site

Kurigrām, Bangladesh