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

NCT04334538 | Completed

• 1 other identifier: 202003153
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition, Child

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• fecal 16S rRNA configuration after 4 weeks of feeding

  after 4 weeks of feeding

Study Arms (2)

S-RUTF

ACTIVE COMPARATOR

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

oat-RUTF

EXPERIMENTAL

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

Interventions

S-RUTF DIETARY_SUPPLEMENT

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.

S-RUTF

oat RUTF DIETARY_SUPPLEMENT

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.

oat-RUTF

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Children currently involved in another research trial or feeding program
• Children developmentally delayed
• have a chronic debilitating illness
• history of peanut or milk allergy

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Project Peanut Butter, Sierra Leone: collaborator
• Ministry of Health and Sanitation, Sierra Leone: collaborator

Study Sites (1)

Project Peanut Butter

Pujehun, Sierra Leone

Location

Related Publications (1)

• Hendrixson DT, Naskidashvili N, Stephenson KB, Laury ML, Koroma AS, Manary MJ. An Alternative Oat-Containing, Ready-To-Use, Therapeutic Food Does Not Alter Intestinal Permeability or the 16S Ribosomal RNA Fecal Microbiome Configuration Among Children With Severe Malnutrition in Sierra Leone: A Randomized Controlled Trial. J Nutr. 2023 Jan 14;152(12):2744-2753. doi: 10.1093/jn/nxac207.

  PMID: 36055798 DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 6, 2020
• Study Start: March 2, 2021
• Primary Completion: September 6, 2021
• Study Completion: September 6, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

SI (1)