Malnutrition, Child Clinical Trial
Official title:
Acceptability of a Microbiome-directed Food for the Treatment of Children With Uncomplicated Acute Malnutrition in Niger
Verified date | April 2024 |
Source | Epicentre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 274 |
Est. completion date | March 16, 2023 |
Est. primary completion date | March 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 23 Months |
Eligibility | Inclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Niger | Guidan Roumji Health District | Guidan Roumji | |
Niger | Madarounfa Health District | Madarounfa |
Lead Sponsor | Collaborator |
---|---|
Epicentre | Epicentre, Niger, Ministry of Public Health and Social Affairs, Niger, National Nutrition Direction, Niger, Regional Direction of Public Health, Maradi |
Niger,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Acceptability of test dose | Consumption of 75% or more of the test dose within 30 minutes | 30 minutes |
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