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Solutions to Enhance Health with Alternative Treatments (SEHAT) protocol: a double-blinded randomised controlled trial for gut microbiota-targeted treatment of severe acute malnutrition using rice bran in ready-to-use therapeutic foods in Indonesia

Por: Weber · A. M. · Barbazza · S. · Fauzi · M. D. · Rachmadewi · A. · Zuhrina · R. · Putri · F. K. · Campos Ponce · M. · Hoeven · M. v. d. · Rimbawan · R. · Nasution · Z. · Giriwono · P. E. · Wieringa · F. T. · Soekarjo · D. D. · Ryan · E. P.
Introduction

Current formulations of ready-to-use therapeutic foods (RUTFs) to treat severe acute malnutrition (SAM) in children focus on nutrient density and quantity. Less attention is given to foods targeting gut microbiota metabolism and mucosal barrier functions. Heat-stabilised rice bran contains essential nutrients, prebiotics, vitamins and unique phytochemicals that have demonstrated favourable bioactivity to modulate gut microbiota composition and mucosal immunity. This study seeks to examine the impact of RUTF with rice bran on the microbiota during SAM treatment, recovery and post-treatment growth outcomes in Jember, Indonesia. Findings are expected to provide insights into rice bran as a novel food ingredient to improve SAM treatment outcomes.

Methods and analysis

A total of 200 children aged 6–59 months with uncomplicated SAM (weight-for-height z-scores (WHZ)

Ethics and dissemination

The findings of this trial will be submitted to peer-reviewed journals and will be presented at relevant conferences. Ethics approval obtained from the Medical and Health Research Ethical Committee at the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Madain Yogyakarta Ref. No.: KE/FK/0546/EC/2022 and KE/FK/0703/EC/2023 and from Colorado State University IRB#1823, OHRP FWA00000647.

Trial registration number

NCT05319717.

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