ArticleBMC pediatrics2022
Developing shelf-stable Microbiota Directed Complementary Food (MDCF) prototypes for malnourished children: study protocol for a randomized, single-blinded, clinical study.
Article in BMC pediatrics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05094024 (Development of Shelf-Stable, Locally-Sourced, Microbiota-Directed Complementary Foods for Children With Undernutrition), which is not on this map. Cited by 6 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Development of Shelf-Stable, Locally-Sourced, Microbiota-Directed Complementary Foods for Children With Undernutrition
Who cites it
6 citing papers in PubMed, 9 citations in OpenAlex.
- Longitudinal Analysis of the Intestinal Microbiota among a Cohort of Children in Rural and Urban Areas of Pakistan.Nutrients · 2023Trial
- Gut microbial diversity impacts carbohydrate fermentation by children with severe acute malnutrition.iScience · 2026Article
- Trials of improved practices to explore caregivers' practices for childhood nutrition and acceptance of novel interventions for moderately wasted children in a Dhaka slum.Public health nutrition · 2026Article
- Rice Bran Supplements the Nutritional Density of Ready-to-Use Therapeutic Foods: A Targeted Nutrient and Non-Targeted Metabolomic Analysis.Food science & nutrition · 2026Article
- Long-Term Intestinal Epithelial Remodeling Induced by Acute Protein-Energy Malnutrition.bioRxiv : the preprint server for biology · 2025Article
- Etiology, Presentation, and Risk Factors for Diarrheal Syndromes in 3 Sub-Saharan African Countries After the Introduction of Rotavirus Vaccines From the Vaccine Impact on Diarrhea in Africa (VIDA) Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
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Authors and funding
11 authors at 5 institutions in 4 countries.
Funding
Abstract
backgroundChildhood undernutrition is a major public health concern that needs special attention to achieve 2025 global nutrition targets. Moderate acute malnutrition (MAM), manifest as wasting (low weight-for-height), affects 33 million children under 5, yet there are currently no global guidelines for its treatment. We recently performed a randomized-controlled clinical study of a microbiota-directed complementary food formulation (MDCF-2) in 12-18-month-old Bangladeshi children with MAM. The results revealed that MDCF-2, freshly prepared each day, produced a significantly greater improvement in ponderal growth than a standard ready-to-use supplementary food (RUSF), an effect that is associated with repair of the disrupted gut microbial community development that occurs in children with MAM. To test the generalizability of these results in acutely malnourished children at other sites, there is a pressing need for a packaged, shelf-stable, organoleptically-acceptable formulation that is bioequivalent to MDCF-2. This report describes the protocol for a clinical study to evaluate candidate formulations designed to meet these criteria.
methodsA randomized single-blind study will be conducted in 8-12-month-old Bangladeshi children with MAM to compare the efficacy of alternative shelf-stable MDCF prototypes versus the current MDCF-2 formulation that is produced fresh each day. V4-16S rDNA amplicon and shotgun sequencing datasets will be generated from faecal DNA samples collected from each child enrolled in each group prior to, during, and after treatment to determine the abundances of MDCF-2-responsive bacterial taxa. Efficacy will be assessed by quantifying the change in representation of MDCF-2-responsive gut bacterial taxa after 4-weeks of treatment with freshly prepared MDCF-2 compared to their changes in abundance after treatment with the prototype MDCFs. Equivalence will be defined as the absence of a statistically significant difference, after 4-weeks of treatment, in the representation of faecal bacterial taxa associated with the response to MDCF-2 in participants receiving a test MDCF. DISCUSSION: This trial aims to establish acceptability and equivalence with respect to microbiota repair, of scalable, shelf-stable formulations of MDCF-2 in 8-12-month-old Bangladeshi children with moderate acute malnutrition.
trial registrationClinicalTrials.gov (NCT05094024). The trial has been registered before starting enrolment on 23 October 2021.
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