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

Sponsor

Washington University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT04334538

Collaborator

Project Peanut Butter, Sierra Leone (Other), Ministry of Health and Sanitation, Government of Sierra Leone (Other)

129

Enrollment

Location

Arms

6.2

Actual Duration (Months)

20.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition, Child	Dietary Supplement: S-RUTF Dietary Supplement: oat RUTF	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

129 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 2, 2021

Actual Primary Completion Date :

Sep 6, 2021

Actual Study Completion Date :

Sep 6, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.
Experimental: 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.	Dietary Supplement: 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.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Experimental: 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.

Dietary Supplement: oat RUTF

Outcome Measures

Primary Outcome Measures

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

fecal 16S rRNA configuration after 4 weeks of feeding [after 4 weeks of feeding]
Multi amplicon rRNA characterization of flash frozen stool sample

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Project Peanut Butter	Pujehun		Sierra Leone

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Washington University School of Medicine

ClinicalTrials.gov Identifier:

NCT04334538

Other Study ID Numbers:

202003153

First Posted:

Apr 6, 2020

Last Update Posted:

Aug 10, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Malnutrition

Severe Acute Malnutrition

Child Nutrition Disorders

Study Results

No Results Posted as of Aug 10, 2022