An interventional study of S-RUTF and oat RUTF in Malnutrition, Child, sponsored by Washington University School of Medicine. Completed at 1 site in Sierra Leone. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2022-08-10.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
167 studies on the registry are indexed under Child Nutrition Disorders; 36 are open to participants now.
This study's enrollment of 129 is below the median of 402 across 132 interventional studies indexed under Child Nutrition Disorders.
Browse Child Nutrition Disorders studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
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Exclusion Criteria:
Children will receive approximately 175 kcal/kg/d of standard ready to use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.
Dietary Supplement: S-RUTF
Children will receive approximately 175 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.
Dietary Supplement: oat RUTF
Children will receive approximately 175 kcal/kg/d of standard ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.
Children will receive approximately 175 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.
Change of % of lactose excreted between enrollment and 4 weeks after enrollment
%L measured in the urine relative to the amount ingested will be calculated for children in both groups. %L will be categorized as normal (\<0.2%) and abnormal (\>0.2)
Time frame: at week 4 after enrollment
fecal 16S rRNA configuration after 4 weeks of feeding
Multi amplicon rRNA characterization of flash frozen stool sample
Time frame: after 4 weeks of feeding
Ran from Mar 2021 to primary completion in Sep 2021, 6 months.
Of 81 non-industry interventional studies with no phase under Child Nutrition Disorders, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 36. This study's 6 months is below that.
Counting every sponsor, half of 84 studies reached it within 19 months; a quarter within 11 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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