Lanou Hermann Biénou, Somé Jérôme Winetourefa, Koumbem Marie Arsène Aristide, Kouanda Seni
Institut de Recherche en Sciences de la Santé (IRSS), National Centre for Scientific and Technologic Research (CNRST), Wemtenga, Rue 29, 39 Porte 74, 03 P.B. 7192, Ouagadougou, Burkina Faso.
BMC Nutr. 2025 May 13;11(1):92. doi: 10.1186/s40795-025-01045-x.
Acute malnutrition still affects millions of children under five years of age globally each year and contributes to approximately half of all annual childhood deaths. A considerable proportion of patients who recover from acute malnutrition experience poor health and nutrition and eventually relapse after they are discharged from community management of acute malnutrition programs. A microbiota-directed complementary food (MDCF) showed a superior effect compared to standard ready-to-use supplementary food (RUSF) in terms of ponderal growth and potential benefit for bacterial taxa that were correlated with weight-for-height z-score (WHZ). This paper describes a protocol for the MDCF phase III trial on a larger African sample for promoting sustained recovery.
This study is an individually controlled open-label phase III trial to determine the efficacy of MDCF on programmatic and sustained recovery compared to standards RUTF and RUSF. Eligible MAM children will be randomly assigned to MDCF or RUSF and those with SAM to MDCF or RUTF. Supplementation and follow-up visits will be performed following national guidelines for acute malnutrition management. Primary outcomes are programmatic recovery at 12 weeks after enrollment and sustained recovery at 12 weeks after recovery. The secondary outcomes included the mean WHZ, weight-for-age z score, height-for-age z score change, average length of stay, nonresponse, failure and dropout.
The present study is designed to investigate the efficacy of a microbiota-targeted food in treating acute uncomplicated malnutrition and preventing relapses. It will provide evidence as a phase III clinical trial.
Clinicaltrials.gov Protocol registration and results system (NCT05586139). Registered on 2022-10-14. https://register.
gov/ .
急性营养不良每年仍影响全球数百万五岁以下儿童，约占每年儿童死亡总数的一半。相当一部分从急性营养不良中康复的患者健康和营养状况不佳，在从急性营养不良社区管理项目出院后最终会复发。一种微生物群导向的补充食品（MDCF）在体重增长以及对与身高别体重Z评分（WHZ）相关的细菌类群的潜在益处方面，比标准即食补充食品（RUSF）显示出更好的效果。本文描述了一项针对更大规模非洲样本的MDCF三期试验方案，以促进持续康复。
本研究是一项个体对照开放标签三期试验，旨在确定与标准治疗性即用型食品（RUTF）和RUSF相比，MDCF对项目性康复和持续康复的疗效。符合条件的中度急性营养不良（MAM）儿童将被随机分配至MDCF组或RUSF组，重度急性营养不良（SAM）儿童将被随机分配至MDCF组或RUTF组。补充营养和随访将按照国家急性营养不良管理指南进行。主要结局指标为入组后12周的项目性康复以及康复后12周的持续康复。次要结局指标包括平均WHZ、年龄别体重Z评分、年龄别身高Z评分变化、平均住院时间、无反应、治疗失败和退出研究。
本研究旨在调查一种针对微生物群的食品在治疗急性单纯性营养不良和预防复发方面的疗效。作为一项三期临床试验，它将提供证据。
Clinicaltrials.gov方案注册和结果系统（NCT05586139）。于2022年10月14日注册。https://register.
gov/ 。
