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OpenTrials
Completed

NCT Number: NCT04334538

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

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.

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Key information

Conditions

Malnutrition, Child Child Nutrition Disorders Nutrition Disorders Nutritional and Metabolic Diseases

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Project Peanut Butter

Pujehun, Sierra Leone

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change of % of lactose excreted between enrollment and 4 weeks after enrollment

    Time frame: 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 outcomes

  1. fecal 16S rRNA configuration after 4 weeks of feeding

    Time frame: after 4 weeks of feeding

    Multi amplicon rRNA characterization of flash frozen stool sample

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Ministry of Health and Sanitation, Sierra Leone
  • Project Peanut Butter, Sierra Leone

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2020
Registry last updated
Aug 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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