尼日尔马拉迪的两项随机交叉试验：微生物组导向食品对无并发症急性营养不良儿童的可接受性

IF 3.2 Q2 NUTRITION & DIETETICS

Current Developments in Nutrition Pub Date : 2025-06-09 DOI:10.1016/j.cdnut.2025.107484

Susan M Rattigan , Ibrahim Ngoumboute Mbouombouo , Mohamed Antar Abdou Tahirou , Ishita Mostafa , Kazi Nazmus Saqeeb , Souna Garba , Ousmane Guindo , Tahmeed Ahmed , Michael J Barratt , Jeffrey I Gordon , Christopher R Sudfeld , Rebecca F Grais , Sheila Isanaka

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引用次数: 0

摘要

一种新型即用型微生物导向食品（MDF）已被开发出来，用于治疗急性营养不良，其成分可促进营养不良儿童肠道微生物群的修复。目的本研究旨在评估MDF与标准营养护理在急性营养不良儿童中的可接受性。方法进行两项随机交叉试验，包括2个14天的家庭消费期。患有严重急性营养不良（SAM）或中度急性营养不良（MAM）的6至24月龄儿童按1:1的比例随机接受MDF和标准营养护理的顺序，反之亦然。标准的营养护理包括即食治疗食品对SAM和即食补充食品对MAM。主要终点是家庭接受度，定义为在14天的家庭消费期后，返回≥75%的空袋。主要分析是非劣效性分析，如果家中可接受性与标准营养护理的差异的95%置信区间（CI）的下限在- 20个百分点以内，则认为MDF是非劣效性分析。次要结果包括照顾者对儿童喜好的感知，以及照顾者将来使用这两种食物的意愿和偏好。结果随机抽取SAM患儿128例，MAM患儿146例。在SAM儿童的家庭可接受性方面，MDF不逊于标准营养护理(风险差异：−7.0；95% CI下限：- 11.6%)和MAM患儿(风险差异：- 2.3%；95% CI下界：−6.1%)。照顾者在未来使用这两种食物的意愿没有差异。结论smdf在尼日尔6 ~ 24月龄儿童急性营养不良的治疗中是可接受的，在其他急性营养不良高发人群中有待进一步试验。这种新型食品的有效性将在即将进行的试验中进行评估。该试验在clinicaltrials.gov注册为NCT05551819。

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Acceptability of a Microbiome-Directed Food for the Management of Children with Uncomplicated Acute Malnutrition in Maradi, Niger: Two Randomized Crossover Trials

Background

A novel ready-to-use microbiome-directed food (MDF) has been developed for the management of acute malnutrition using ingredients that promote repair of the gut microbiota of undernourished children.

Objectives

This study aims to assess the acceptability of MDF compared with standard nutritional care among children with acute malnutrition.

Methods

Two randomized crossover trials consisting of 2 14-d periods of at-home consumption were conducted. Children aged 6 to <24 mo with severe acute malnutrition (SAM) or moderate acute malnutrition (MAM) were individually randomized in a 1:1 ratio to the sequence of receiving MDF then standard nutritional care, or vice versa. Standard nutritional care consisted of ready-to-use therapeutic food for SAM and ready-to-use supplementary food for MAM. The primary outcome was at-home acceptability, defined as the return of ≥75% of sachets empty after the 14-d at-home consumption period. The primary analysis was a noninferiority analysis, in which MDF was considered noninferior if the lower bound of the 95% confidence interval (CI) of the difference in at-home acceptability comparing MDF with standard nutritional care was within −20 percentage points. Secondary outcomes included caregiver’s perception of the child’s liking, as well as caregiver willingness to use in the future and preference between the 2 foods.

Results

In all, 128 children with SAM and 146 children with MAM were randomized. MDF was noninferior to standard nutritional care in terms of at-home acceptability among children with SAM (risk difference: −7.0; 95% CI lower bound: −11.6%) and among children with MAM (risk difference: −2.3%; 95% CI lower bound: −6.1%). There were no differences in caregiver willingness to use either food in future.

Conclusions

MDF is acceptable for the management of acute malnutrition in children aged 6 to <24 mo in Niger and should be further tested in other populations with a high prevalence of acute malnutrition. Effectiveness of the novel food will be assessed in forthcoming trials.