Clinical trial NCT05551819: Acceptability of a Microbiome-directed Food in Young Children With Acute Malnutrition
Official title: Acceptability of a Microbiome-directed Food for the Treatment of Children With Uncomplicated Acute Malnutrition in Niger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition, Child
Lead sponsor: Epicentre
Sponsor class: OTHER
Collaborators: name: Epicentre, Niger
name: National Nutrition Direction, Niger
name: Ministry of Public Health and Social Affairs, Niger
name: Regional Direction of Public Health, Maradi
First posted: 2022-09-23
Enrollment: 274
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of at-home ration
timeFrame: 2 weeks
measure: Acceptability of test dose
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Guidan Roumji
country: Niger
facility: Guidan Roumji Health District
city: Madarounfa
country: Niger
facility: Madarounfa Health District
Study officials:
References: