Chandwe, K, Bwakura-Dangarembizi, M, Amadi, B, Tawodzera, G, Ngosa, D, Dzikiti, A, Chulu, N, Makuyana, R, Zyambo, K, Mutasa, K, Mulenga, C, Besa, E, Sturgeon, J, Mudzingwa, S, Simunyola, B, Kazhila, L, Zyambo, M, Sonkwe, H, Mutasa, B, Chipunza, M, Sauramba, V, Langhaug, L, Mudenda, V, Murch, S, Hill, S, Playford, Raymond J. ORCID: https://orcid.org/0000-0003-1235-8504, VanBuskirk, K, Prendergast, A and Kelly, P (2024) Malnutrition enteropathy in Zambian and Zimbabwean children with severe acute malnutrition: A multi-arm randomized phase II trial. Nature Communications, 15.

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Abstract

Malnutrition underlies almost half of all child deaths globally. Severe Acute Malnutrition (SAM) carries unacceptable mortality, particularly if accompanied
by infection or medical complications, including enteropathy. We evaluated four interventions for malnutrition enteropathy in a multi-centre
phase II multi-arm trial in Zambia and Zimbabwe and completed in 2021. The purpose of this trial was to identify therapies which could be taken forward into phase III trials. Children of either sex were eligible for inclusion if aged 6–59 months and hospitalised with SAM (using WHO definitions: WLZ <−3, and/or MUAC <11.5 cm, and/or bilateral pedal oedema), with written, informed consent from the primary caregiver.We randomised 125 children hospitalised
with complicated SAM to 14 days treatment with (i) bovine colostrum(n = 25), (ii) N-acetyl glucosamine (n = 24), (iii) subcutaneous teduglutide (n = 26), (iv) budesonide (n = 25) or (v) standard care only (n = 25). The primary endpoint
was a composite of faecal biomarkers (myeloperoxidase, neopterin, α1-antitrypsin). Laboratory assessments, but not treatments, were blinded. Perprotocol analysis used ANCOVA, adjusted for baseline biomarker value, sex, oedema, HIV status, diarrhoea, weight-for-length Z-score, and study site, with pre-specified significance of P < 0.10. Of 143 children screened, 125 were randomised. Teduglutide reduced the primary endpoint of biomarkers of
mucosal damage (effect size −0.89 (90% CI: −1.69,−0.10) P = 0.07), while colostrum (−0.58 (−1.4, 0.23) P = 0.24), N-acetyl glucosamine (−0.20 (−1.01, 0.60) P = 0.67), and budesonide (−0.50 (−1.33, 0.33) P = 0.32) had no significant effect. All interventions proved safe. This work suggests that treatment of enteropathy may be beneficial in children with complicated malnutrition. The trial was registered at ClinicalTrials.gov with the identifier NCT03716115

Item Type:	Article
Identifier:	10.1038/s41467-024-45528-0
Subjects:	Medicine and health > Child health
Depositing User:	Raymond J. Playford
Date Deposited:	14 Sep 2024 10:31
Last Modified:	04 Nov 2024 11:21
URI:	https://repository.uwl.ac.uk/id/eprint/12444

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