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

• Sponsor: Epicentre (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05551819
• Collaborator: Epicentre, Niger (Other), National Nutrition Direction, Niger (Other), Ministry of Public Health and Social Affairs, Niger (Other), Regional Direction of Public Health, Maradi (Other)
• Enrollment: 292
• Arms: 2
• Anticipated Duration (Months): 2.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Malnutrition, Child	Dietary Supplement: MDF then RUTF/RUSF; Dietary Supplement: RUTF/RUSF then MDF	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 292 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acceptability of a Microbiome-directed Food for the Treatment of Children With Uncomplicated Acute Malnutrition in Niger
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Dec 15, 2022
• Anticipated Study Completion Date: Dec 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Feeding Order 1 MDF then RUTF/RUSF	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.
Experimental: Feeding Order 2 RUTF/RUSF then MDF	Dietary Supplement: 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.

Outcome Measures

Primary Outcome Measures

1. Acceptability of test dose [30 minutes]

   Consumption of 75% or more of the test dose within 30 minutes

2. Acceptability of at-home ration [2 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 23 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Epicentre
• Epicentre, Niger
• National Nutrition Direction, Niger
• Ministry of Public Health and Social Affairs, Niger
• Regional Direction of Public Health, Maradi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sheila Isanaka, Associate Professor, Harvard School of Public Health (HSPH)
• ClinicalTrials.gov Identifier: NCT05551819
• Other Study ID Numbers: 823779-MDF Acceptability Niger
• First Posted: Sep 23, 2022
• Last Update Posted: Sep 23, 2022
• Last Verified: Sep 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Malnutrition; Child Nutrition Disorders

Study Results

No Results Posted as of Sep 23, 2022