Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition

Malnutrition, Child Clinical Trial

Official title:

Acceptability of a Microbiome-directed Food for the Treatment of Children With Uncomplicated Acute Malnutrition in Niger

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05551819
• Other study ID #: 823779-MDF Acceptability Niger
• Status: Completed
• Phase: N/A
• Start date: October 26, 2022
• Est. completion date: March 16, 2023

Study information

• Verified date: April 2024
• Source: Epicentre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the acceptability a microbiome-directed food (MDF) with standard formulations of therapeutic/supplementary foods for the treatment of acute malnutrition using a 2 x 2 crossover design.

Description:

A randomized controlled trial will be conducted to assess the effectiveness of a microbiome-directed food (MDF) for treatment of uncomplicated acute malnutrition among children 6 to <24 months of age in Niger. MDF will be compared to standard ready-to-use therapeutic foods (RUTF) for children with severe acute malnutrition (SAM) and to standard ready-to-use supplementary foods (RUSF) for children with moderate acute malnutrition (MAM). The acceptability and utilization of MDF will be assessed in this preliminary acceptability study before the proposed effectiveness trial. The results of this preliminary acceptability study will be used to inform expectations of MDF use during the subsequent randomized effectiveness trial.

Children aged 6 to < 24 months will be eligible for enrollment in the acceptability trial on the day of their admission for treatment of uncomplicated severe or moderate acute malnutrition. Participants will be purposively selected to ensure balance by child age (6-11 vs 12 to < 24 months) and sex. Recruitment will occur continuously (e.g. without sampling on consecutive working days) among all eligible children at 2 study health centers until the target sample size is achieved.

After providing written informed consent, children will be randomized to 1 of 2 feeding orders (MDF vs RUTF/RUSF). Children will be randomized and provided with one product for the first two weeks then crossover to consume the second product for a second two weeks.

At each follow up visit, study nurses will ask caregivers rate their child's liking of the supplement on a 5-point Likert scale, as well as record child weight and any morbidity or adverse event since last visit before dispensing the next supply of food. Caregivers will also be asked to describe at-home utilization, including the food consumed by the child, current eating patterns in relation to other household foods (e.g. use at mealtimes, as a complete replacement, replacement of specific food items), sharing or selling practices in the home and willingness to use the supplement in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: March 16, 2023
• Est. primary completion date: March 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 23 Months

Eligibility

Inclusion Criteria:

• Are eligible for outpatient treatment of severe or moderate acute malnutrition according to the national protocol

• Are between 6 and <24 months of age

• Reside in the study catchment area and will remain there for at least 1 month

• Have no known allergy or contraindication to study product or standard treatment ingredients

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition, Child

Intervention

Dietary Supplement:
• MDF then RUTF/RUSF
Children randomized to feeding order 1: children will be provided MDF for the first two weeks then crossover to consume RUTF/RUSF for a second two weeks.
• RUTF/RUSF then MDF
Children randomized to feeding order 2: children will be provided RUTF/RUSF for the first two weeks then crossover to consume MDF for a second two weeks.

Locations

Country	Name	City	State
Niger	Guidan Roumji Health District	Guidan Roumji
Niger	Madarounfa Health District	Madarounfa

Sponsors (5)

Lead Sponsor	Collaborator
Epicentre	Epicentre, Niger, Ministry of Public Health and Social Affairs, Niger, National Nutrition Direction, Niger, Regional Direction of Public Health, Maradi

Country where clinical trial is conducted

Niger, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of at-home ration	Consumption of 75% or more of the supplement provided during each 2-week period, where consumption is defined as total amount of food provided minus the total amount of food returned unused divided by the total amount of food provided.	2 weeks
Primary	Acceptability of test dose	Consumption of 75% or more of the test dose within 30 minutes	30 minutes