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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04334538
Other study ID # 202003153
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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