Department of Public Health, University of the Punjab, Lahore, Pakistan.
Department of Food Science and Human Nutrition, University of Veterinary and Animal Sciences, Lahore, Pakistan.
Trials. 2024 Nov 26;25(1):798. doi: 10.1186/s13063-024-08647-z.
The anti-inflammatory and antimicrobial benefits of prebiotics may present an affordable and cost-effective strategy for 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.
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 the experimental group receiving ready-to-use therapeutic food (RUTF) plus prebiotics and the active comparator group receiving RUTF plus starch for 2 months duration (8 weeks). Healthy children with matching age and gender will be recruited to placebo comparator group and will receive starch as a placebo during the study period. A total of 58 participants will be recruited to each arm with 1:1:1 allocation ratio following a pre-defined inclusion and exclusion criteria. 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.
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 plus prebiotic on the gut microbiome diversity of children, leading to medical evidence for designing the large-scale studies.
The present trial is registered at ClinicalTrials.gov with identifier No: NCT06155474 and registration date 4 December 2023.
益生菌的抗炎和抗菌作用为预防和治疗营养不良提供了一种经济实惠且具有成本效益的策略。因此，本试验旨在评估益生菌对严重急性营养不良（SAM）儿童肠道微生物群的影响。
本研究设计为前瞻性、双盲、三臂、多中心随机对照试验，纳入 6-59 个月大的无并发症 SAM 儿童，实验组接受即食治疗食品（RUTF）+益生菌，活性对照组接受 RUTF+淀粉，持续 2 个月（8 周）。将招募年龄和性别匹配的健康儿童进入安慰剂对照组，在研究期间接受淀粉作为安慰剂。根据预先确定的纳入和排除标准，每组将招募 58 名参与者，分配比例为 1:1:1。肠道微生物多样性的结果将作为主要结局，而身高/身长体重指数、上臂中部周长、神经发育评估和体重积累将作为次要结局。数据收集和评估将在基线和试验结束时（第 8 周）进行，同时每两周进行一次安全性监测。分析时将遵循意向治疗原则。
综上所述，本试验的结果将通过评估 RUTF+益生菌对儿童肠道微生物多样性的影响，为治疗和管理 SAM 儿童提供有用的见解和高质量的数据，为设计大规模研究提供医学证据。
本试验在 ClinicalTrials.gov 注册，标识符为 NCT06155474，注册日期为 2023 年 12 月 4 日。
