Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition

Study Overview
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Brief Summary
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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.

Official Title
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Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition

Conditions
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Malnutrition, Child

Intervention / Treatment
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* Dietary Supplement: S-RUTF
* Dietary Supplement: oat RUTF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mid-upper arm circumference (MUAC) <11.5 cm Exclusion Criteria: Children currently involved in another research trial or feeding program Children developmentally delayed have a chronic debilitating illness history of peanut or milk allergy

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: S-RUTF<br>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. | Dietary Supplement: S-RUTF<br>* 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.<br>|
| Experimental: oat-RUTF<br>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. | Dietary Supplement: oat RUTF<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |