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NCT04334538

Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition

Washington University School of Medicine·ClinicalTrials.gov·dietary supplementRecruiting
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Study focus
Disease/Condition
Malnutrition, Child
Drug/Device/Intervention
S-RUTF
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Washington University School of Medicine
Location
Pujehun, Sierra Leone
Timeline & enrollment
Phase
N/A
Start date
Mar 02, 2021
End date
Dec 31, 2021
Enrollment
120 participants
Primary outcome

Change of % of lactose excreted between enrollment and 4 weeks after enrollment

Summary

Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF
 requires that there be no oil separation in these products necessitating the use of
 emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an
 exclusive diet of RUTF is unknown. The PIs have recently completed a randomized,
 triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the
 alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This
 study demonstrated higher rates of recovery among children receiving the oat-RUTF. The
 investigators hypothesize that this benefit may be due to the lack of emulsifier in the
 oat-RUTF resulting in improved intestinal health.This research project is a double-blind,
 randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats
 and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and
 effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural
 and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.

ICD-10 classifications
MalnutritionMalnutrition in pregnancySequelae of malnutrition and other nutritional deficienciesMalnutrition-related diabetes mellitusMalnutrition-related diabetes mellitus with unspecified complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04334538
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04334538 through Pure Global AI's free database. This phase not specified trial is sponsored by Washington University School of Medicine and is currently Recruiting. The study focuses on Malnutrition, Child. Target enrollment is 120 participants.

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