ArticleCurrent developments in nutrition2025
Acceptability of a Microbiome-Directed Food for the Management of Children with Uncomplicated Acute Malnutrition in Maradi, Niger: Two Randomized Crossover Trials.
Article in Current developments in nutrition, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05551819 (Acceptability of a Microbiome-directed Food for the Treatment of Children With Uncomplicated Acute Malnutrition in Niger), which is not on this map. Cited by 1 paper.
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Acceptability of a Microbiome-directed Food for the Treatment of Children With Uncomplicated Acute Malnutrition in Niger
Who cites it
1 citing paper in PubMed.
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13 authors.
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No grant is acknowledged in the PubMed record.
Abstract
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. Trial registration number: This trial was registered at clinicaltrials.gov as NCT05551819.
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