Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition
1 other identifier
interventional
274
1 country
2
Brief Summary
This study will compare the acceptability a microbiome-directed food (MDF) with standard formulations of therapeutic/supplementary foods for the treatment of acute malnutrition using a 2 x 2 crossover design.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2022
CompletedFirst Posted
Study publicly available on registry
September 23, 2022
CompletedStudy Start
First participant enrolled
October 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2023
CompletedApril 17, 2024
April 1, 2024
5 months
September 20, 2022
April 16, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Acceptability of at-home ration
Consumption of 75% or more of the supplement provided during each 2-week period, where consumption is defined as total amount of food provided minus the total amount of food returned unused divided by the total amount of food provided.
2 weeks
Acceptability of test dose
Consumption of 75% or more of the test dose within 30 minutes
30 minutes
Study Arms (2)
Feeding Order 1
EXPERIMENTALMDF then RUTF/RUSF
Feeding Order 2
EXPERIMENTALRUTF/RUSF then MDF
Interventions
Children randomized to feeding order 1: children will be provided MDF for the first two weeks then crossover to consume RUTF/RUSF for a second two weeks.
Children randomized to feeding order 2: children will be provided RUTF/RUSF for the first two weeks then crossover to consume MDF for a second two weeks.
Eligibility Criteria
You may qualify if:
- Are eligible for outpatient treatment of severe or moderate acute malnutrition according to the national protocol
- Are between 6 and \<24 months of age
- Reside in the study catchment area and will remain there for at least 1 month
- Have no known allergy or contraindication to study product or standard treatment ingredients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Epicentrelead
- Epicentre, Nigercollaborator
- National Nutrition Direction, Nigercollaborator
- Ministry of Public Health and Social Affairs, Nigercollaborator
- Regional Direction of Public Health, Maradicollaborator
Study Sites (2)
Guidan Roumji Health District
Guidan Roumji, Niger
Madarounfa Health District
Madarounfa, Niger
Related Publications (1)
Rattigan SM, Mbouombouo IN, Abdou Tahirou MA, Mostafa I, Saqeeb KN, Garba S, Guindo O, Ahmed T, Barratt MJ, Gordon JI, Sudfeld CR, Grais RF, Isanaka S. Acceptability of a Microbiome-Directed Food for the Management of Children with Uncomplicated Acute Malnutrition in Maradi, Niger: Two Randomized Crossover Trials. Curr Dev Nutr. 2025 Jun 9;9(7):107484. doi: 10.1016/j.cdnut.2025.107484. eCollection 2025 Jul.
PMID: 40672125DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 20, 2022
First Posted
September 23, 2022
Study Start
October 26, 2022
Primary Completion
March 16, 2023
Study Completion
March 16, 2023
Last Updated
April 17, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share