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

Primary Investigator

  • David Taylor Hendrixson, MD

Study Period

June 2020 - August 2020

Study Description

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.

Study Arms

  • Active Comparator: S-RUTF
  • Experimental: oat-RUTF

Primary Outcomes

  • Change of % of lactose excreted between enrollment and 4 weeks after enrollment [ Time Frame: at week 4 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 n

Study Interventions

  • Standard Lipid-Based Nutrient Supplements (LNS)
  • Plant-source protein

Research Gaps

  • Effectiveness

    How well do different food compositions and interventions prevent or treat undernutrition, when implemented "on the ground"?

  • Innovation

    What novel food-based products and programming methods effectively prevent and treat undernutrition?

Study Population

120