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

Not Applicable

Completed

• Conditions: Malnutrition, Child
• Interventions: Dietary Supplement: S-RUTF; Dietary Supplement: oat RUTF

• Registration Number: NCT04334538
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-06
• Study Start: 2021-03-02
• Primary Completion: 2021-09-06
• Study Completion: 2021-09-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• mid-upper arm circumference (MUAC) <11.5 cm

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-RUTF	S-RUTF	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.
oat-RUTF	oat RUTF	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.

Primary Outcome Measures

Name	Time	Method
Change of % of lactose excreted between enrollment and 4 weeks after enrollment	at week 4 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)

Secondary Outcome Measures

Name	Time	Method
fecal 16S rRNA configuration after 4 weeks of feeding	after 4 weeks of feeding	Multi amplicon rRNA characterization of flash frozen stool sample

Trial Locations

Locations (1)

Project Peanut Butter; 🇸🇱 Pujehun, Sierra Leone