The Gut Microbiota-Targeted Treatment of Severe Acute Malnutrition Using Rice Bran in Ready-to-Use Therapeutic Foods: A Randomized Controlled Trial in Indonesia

Objectives: In Indonesia, severe acute malnutrition (SAM) affects over 2 million children under the age of 5, however, due to lack of availability of ready-to-use therapeutic foods (RUTFs) only ∼1% have access to adequate treatment. Current RUTF treatment is aimed at immediate benefits such as weight gain and reduction in mortality rates but recovered children have persistent dysbiotic gut microbiota, leaving them susceptible to infection and malnutrition relapse. Rice bran is a locally available food ingredient that is rich in prebiotic fibers and positively influences the gut microbiome as well as supports healthy growth. This study investigated the effect of adding rice bran to a locally produced RUTF for the treatment of SAM in Jember, Indonesia.
Methods: Children aged 6–59 months (n=200) with uncomplicated SAM or approaching SAM (weight-for-height z-scores (WHZ) < −2.5, or mid-upper arm circumference (MUAC) < 115mm) were enrolled in a double-blinded RCT (ClinicalTrials.gov:NCT05319717). Children received either a locally produced RUTF or the same RUTF with 5% rice bran and were provided with 8 weeks of treatment, followed by 8 weeks of monitoring. RUTF effectiveness was tested by determining changes in anthropometric status (e.g. weight gain, WHZ and MUAC) as primary outcomes in an intention-to-treat analysis for all ages and split by age groups (6-23 months and 24-59 months old).
Results: The study revealed improved growth outcomes in both treatment arms. At week 4, children in the RUTF-A∗ arm compared to RUTF-B∗ had greater weight gain velocity for all ages (p=0.036) and children aged 24-59 months (p=0.023). In contrast, at week 12, children in the RUTF-B∗ arm compared to RUTF-A∗ had greater weight gain velocity for all ages (p=0.01), and in children aged 24-59 months had greater weight gain velocity (p=0.02), weight (p=0.03), and WHZ (p=0.046). There were no statistically significant differences in study compliance between treatment arms.
Conclusions: Addition of the prebiotic rice bran to RUTF modified the growth trajectories of children receiving treatment for SAM. This investigation provides new insights into the effectiveness of a locally produced, rice bran-based RUTF for the treatment of SAM. *Blinded for analysis, unblinding in March 2024.
Funding Sources: Thrasher Research Fund and NIH/NIAID T32 AI162691.