Effect of an Alternative RUTF on Intestinal Permeability in Children with Severe Acute Malnutrition
Mark Manary, MD
BACKGROUND: Severe acute malnutrition (SAM) is a debilitating condition that confers increased risk for mortality and decreased long-term cognitive outcomes in children aged 6 to 59 months. 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. A recent randomized controlled clinical trial of an alternative oat RUTF (oat-RUTF) formulation demonstrated improved recovery rates when compared to standard RUTF (s-RUTF). GAP: The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. HYPOTHESIS: We hypothesize that children consuming oat-RUTF without emulsifier will have decreased gut permeability and higher rates of weight gain and mid-upper arm circumference (MUAC) gain when compared to children consuming s-RUTF METHODS: 120 Children aged 6-59 months with SAM as defined by a MUAC <11.5 cm and attending established feeding clinics in Sierra Leone will be enrolled in this randomized, double-blinded controlled clinical trial. Participants will be randomized to s-RUTF or oat-RUTF. Participants will return to clinic every 2 weeks for anthropometric assessment and evaluation of tolerance of the study foods. Participants will remain on the study food until they reach a MUAC ≥12.5 or have received 12 weeks of therapy. Dual absorption sugar test will be performed at enrollment and week 4 of therapy. The primary outcome will be lactose to mannitol ratio at week 4 of therapy. Secondary outcomes will be rate of weight gain (g/kg/d) and rate of MUAC gain (mm/d). RESULTS: Pending. IMPACT: If an alternative oat RUTF without emulsifier results in improved intestinal health in children receiving treatment for SAM, this will bolster evidence for policy makers to adopt alternative cost-effective formulations.