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| Name | Class |
|---|---|
| Project Peanut Butter, Sierra Leone | UNKNOWN |
| Ministry of Health and Sanitation, Sierra Leone | OTHER_GOV |
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Ready-to-use therapeutic food (RUTF) is the standard of care for the treatment of SAM. UNICEF requires that there be no oil separation in these products necessitating the use of emulsifiers. The effect of emulsifiers on gut health and integrity in children receiving an exclusive diet of RUTF is unknown. The PIs have recently completed a randomized, triple-blind, controlled, clinical equivalency trial in Sierra Leone comparing the alternative oat RUTF (oat-RUTF) to standard RUTF on recovery rates in children with SAM. This study demonstrated higher rates of recovery among children receiving the oat-RUTF. The investigators hypothesize that this benefit may be due to the lack of emulsifier in the oat-RUTF resulting in improved intestinal health.This research project is a double-blind, randomized, controlled clinical effectiveness trial comparing a novel RUTF containing oats and no emulsifier and standard RUTF on recovery from severe acute malnutrition (SAM) and effects on intestinal health. The trial will be conducted in up to 40 PHUs in Western Rural and Pujehun Districts where supplementary feeding programs (SFP) are not currently available.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-RUTF | Active Comparator | Children will receive approximately 175 kcal/kg/d of standard ready to use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child. |
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| oat-RUTF | Experimental | Children will receive approximately 175 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-RUTF | Dietary Supplement | Children will receive approximately 175 kcal/kg/d of standard ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of % of lactose excreted between enrollment and 4 weeks after enrollment | %L measured in the urine relative to the amount ingested will be calculated for children in both groups. %L will be categorized as normal (<0.2%) and abnormal (>0.2) | at week 4 after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| fecal 16S rRNA configuration after 4 weeks of feeding | Multi amplicon rRNA characterization of flash frozen stool sample | after 4 weeks of feeding |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Project Peanut Butter | Pujehun | Sierra Leone |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36055798 | Derived | Hendrixson DT, Naskidashvili N, Stephenson KB, Laury ML, Koroma AS, Manary MJ. An Alternative Oat-Containing, Ready-To-Use, Therapeutic Food Does Not Alter Intestinal Permeability or the 16S Ribosomal RNA Fecal Microbiome Configuration Among Children With Severe Malnutrition in Sierra Leone: A Randomized Controlled Trial. J Nutr. 2023 Jan 14;152(12):2744-2753. doi: 10.1093/jn/nxac207. |
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| oat RUTF | Dietary Supplement | Children will receive approximately 175 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child. |
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