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

Malnutrition, Child Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334538
• Other study ID #: 202003153
• Status: Completed
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: September 6, 2021

Study information

• Verified date: August 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: September 6, 2021
• Est. primary completion date: September 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child
• Severe Acute Malnutrition

Intervention

Dietary Supplement:
• 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
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.

Locations

Country	Name	City	State
Sierra Leone	Project Peanut Butter	Pujehun

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Ministry of Health and Sanitation, Government of Sierra Leone, Project Peanut Butter, Sierra Leone

Country where clinical trial is conducted

Sierra Leone, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	fecal 16S rRNA configuration after 4 weeks of feeding	Multi amplicon rRNA characterization of flash frozen stool sample	after 4 weeks of feeding