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.
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.
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DOI：
10.1136/bmjopen-2023-076805
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发表时间：
2023-11-24
期刊：
影响因子：
2.9
通讯作者：
中科院分区：
文献类型：
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作者：
目前用于治疗儿童严重急性营养不良 (SAM) 的即用治疗食品 (RUTF) 配方侧重于营养密度和数量。针对肠道微生物群代谢和粘膜屏障功能的食物较少受到关注。热稳定米糠含有必需营养素、益生元、维生素和独特的植物化学物质，这些物质已被证明具有调节肠道微生物群组成和粘膜免疫的良好生物活性。本研究旨在研究印度尼西亚任抹的 RUTF 与米糠在 SAM 治疗、恢复和治疗后生长结果期间对微生物群的影响。研究结果预计将有助于深入了解米糠作为一种新型食品成分，以改善 SAM 治疗效果。总共 200 名年龄在 6-59 个月、患有无并发症 SAM（身高体重 z 值 (WHZ) <−3，或中上臂围 (MUAC) <115 mm 或双侧凹陷性水肿 +/++）或接近 SAM (WHZ<−2.5) 的儿童将被纳入一项双盲、随机对照试验。主动控制组的儿童将收到本地生产的 RUTF；干预组的人员将收到含有 5% 米糠的当地 RUTF。儿童将接受为期 8 周的每日 RUTF 治疗，并接受为期 8 周的随访监测。主要结果包括通过体重变化、WHO 生长 z 分数、MUAC 和发病率来衡量 RUTF 的有效性。次要结局包括肠道微生物组和干血斑代谢组的调节、第 8 周和第 12 周恢复的儿童百分比以及第 16 周营养不良复发。将对每个结局进行意向治疗分析。该试验的结果将提交给同行评审期刊，并将在相关会议上公布。伦理批准获得了日惹加查马达大学医学、公共卫生和护理学院医学和健康研究伦理委员会的批准。编号：KE/FK/0546/EC/2022 和 KE/FK/0703/EC/2023 以及科罗拉多州立大学 IRB#1823、OHRP FWA00000647。 NCT05319717。
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. A total of 200 children aged 6–59 months with uncomplicated SAM (weight-for-height z-scores (WHZ) <−3, or mid-upper arm circumference (MUAC) <115 mm or having bilateral pitting oedema +/++) or approaching SAM (WHZ<−2.5) will be enrolled in a double-blinded, randomised controlled trial. Children in the active control arm will receive a locally produced RUTF; those in the intervention arm will receive the local RUTF with 5% rice bran. Children will receive daily RUTF treatment for 8 weeks and be monitored for 8 weeks of follow-up. Primary outcomes include the effectiveness of RUTF as measured by changes in weight, WHO growth z-scores, MUAC and morbidity. Secondary outcomes include modulation of the gut microbiome and dried blood spot metabolome, the percentage of children recovered at weeks 8 and 12, and malnutrition relapse at week 16. An intention-to-treat analysis will be conducted for each outcome. 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. NCT05319717.
影响因子：
5.9
作者：
Rachmadewi, Asrinisa;Soekarjo, Damayanti D.;Bait, Blandina Rosalina;Suryantan, Julia;Noor, Rivani;Rah, Jee Hyun;Wieringa, Frank T.
通讯作者：
Wieringa, Frank T.