Effects of prebiotics on microbial diversity and abundance in young children with acute malnutrition: Study protocol for a multi-centered, double-blinded randomized controlled trial

Background: The anti-inflammatory and antimicrobial benefits of prebiotics may present an affordable and cost-effective strategy in not only the prevention but also treatment of malnutrition. Therefore, the present trial has been designed with the aim to evaluate the role of prebiotics on the gut microbiome of severe acute malnourished (SAM) children. Methods: The study is designed as a prospective, double-blinded, triple-armed, multi-centered randomized controlled trial, with 6–59 months old uncomplicated SAM children recruited to experimental group receiving RUTF+prebiotics and active comparator group receiving RUTF+starch. Healthy children with matching age and gender will be recruited to placebo comparator group and will receive starch as a placebo. A total of 53 participants will be recruited to each arm with 1:1:1 allocation ratio following a pre-defined inclusion and exclusion criteria for eight weeks. The results of the gut microbiome diversity will serve as the primary outcome, while weight-for-height/length z-score, mid-upper-arm circumference, neurodevelopment assessment and body mass accumulation will serve as the secondary outcome. Data collection and evaluations will be conducted at baseline and at the end of the trial (week 8) while the safety monitoring will be conducted at every second week. For analysis, the principles of intention-to-treat will be followed. Conclusions: Conclusively, the results of the present trial would provide useful insights and high-quality data for the treatment and management of SAM children by evaluating the effect of RUTF+prebiotic on the gut microbiome diversity of children, leading to medical evidence for designing the large-scale studies. Trial registration: The present trial is registered at ClinicalTrials.gov with identifier No: NCT06155474 and registration date 04/12/23.