Legume-supplemented feed for children hospitalised with severe malnutrition: A Phase II trial.

Children hospitalised with severe malnutrition have high mortality and readmission rates post-discharge. Current milk-based formulations target restoring ponderal growth but not modification of gut barrier integrety or microbiome which increase risk of gram-negative sepsis and poor outcomes. We propose that legume-based feeds rich in fermentable carbohydrates will promote better gut health and improve overall outcomes.We conducted an open-label Phase II trial at Mbale and Soroti Regional Referral Hospitals, Uganda involving 160 children aged 6 months-5 years with severe malnutrition (mid-upper arm circumference (MUAC) <11.5cm and/or nutritional oedema). Children were randomised to a lactose-free, chickpea-enriched legume paste feed (LF) (n=80) versus WHO standard F75/F100 feeds (n=80). Co-primary outcomes were change in MUAC and mortality to Day 90. Secondary outcomes included weight gain (>5 g/kg/day), de novo development of diarrhoea, time to diarrhoea and oedema resolution. Day 90 MUAC increase was marginally lower in LF versus WHO arm ( 1.1 cm (IQR 1.1) vs 1.4cm (IQR 1.40) p=0.09 ; Day 90 mortality was similar 11/80 (13.8%) vs 12/80 (15%) respectively OR 0.91 (95% CI 0.40 -2.07) p=0.83. There were no differences in any of the other secondary outcomes. Owing to initial poor palatability of the legume feed 10 children switched to WHO feeds. Per protocol analysis indicated a trend to lower Day 90 mortality and readmission rates in the legume feed ( 6/60: (10%) and (2/60: 3%) vs WHO feeds ( 12/71: 17.5%) and (4/71: 6%) respectively.Further refinement of legume feeds and clinical trials are warrented given the poor outcomes in children with severe malnutrition. Trial registration ISRCTN 10309022.