Legume-supplemented feed for children hospitalised with severe malnutrition: a phase II trial
Author(s)
Type
Journal Article
Abstract
Children hospitalised with severe malnutrition have high mortality and readmission rates post-discharge. Current milk-based formulations target restoring ponderal growth but not the modification of gut barrier integrity or microbiome which increases the 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 to 5 years with severe malnutrition (mid-upper arm circumference (MUAC) < 11·5 cm and/or nutritional oedema). Children were randomised to a lactose-free, chickpea-enriched legume paste feed (LF) (n 80) v. 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/d), de novo development of diarrhoea, time to diarrhoea and oedema resolution. Day 90 MUAC increase was marginally lower in LF v. WHO arm (1·1 cm (interquartile range (IQR) 1·1) v. 1·4 cm (IQR 1·40), P = 0·09); day 90 mortality was similar (11/80 (13·8 %) v. 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 LF, ten children switched to WHO feeds. Per-protocol analysis indicated a trend to lower day 90 mortality and readmission rates in the LF (6/60 (10 %) and 2/60(3 %)) v. WHO feeds (12/71(17·5 %) and 4/71(6 %)). Further refinement of LF and clinical trials are warranted, given the poor outcomes in children with severe malnutrition.
Date Issued
2024-08-14
Date Acceptance
2024-03-13
Citation
The British Journal of Nutrition: an international journal of nutritional science, 2024, 132 (3), pp.372-381
ISSN
0007-1145
Publisher
Cambridge University Press
Start Page
372
End Page
381
Journal / Book Title
The British Journal of Nutrition: an international journal of nutritional science
Volume
132
Issue
3
Copyright Statement
© The Author(s), 2024. Published by Cambridge University Press on behalf of The Nutrition Society. This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
License URL
Identifier
https://www.cambridge.org/core/journals/british-journal-of-nutrition/article/legumesupplemented-feed-for-children-hospitalised-with-severe-malnutrition-a-phase-ii-trial/7E60B1A84BAA9EEE5C3BD507E2D34344
Publication Status
Published
Date Publish Online
2024-06-04