Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition - Trial NCT04334538
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.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Washington University School of Medicine
Timeline & Enrollment
N/A
Mar 02, 2021
Dec 31, 2021
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
Data Source
ClinicalTrials.gov
NCT04334538
Non-Device Trial