Clinical Trials Logo

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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05551819
Study type Interventional
Source Epicentre
Contact
Status Completed
Phase N/A
Start date October 26, 2022
Completion date March 16, 2023

See also
  Status Clinical Trial Phase
Completed NCT05012592 - Reducing Malnutrition and Helminthic Infectious Disease Among Primary School Children by the School Nurses N/A
Completed NCT04216043 - Milk Matters in Malnutrition, is it the Lactose or Dairy Protein? N/A
Enrolling by invitation NCT05603793 - YoUng Adolescents' behaViour, musculoskeletAl heAlth, Growth & Nutrition
Completed NCT03573713 - Decreasing Stunting by Reducing Maternal Depression in Uganda: A Cluster Randomized Controlled Trial (CRCT) for Improved Nutrition Outcomes N/A
Not yet recruiting NCT05792514 - The Reliable Nutritional Risk Screening Tools
Recruiting NCT04109352 - Labelled Carbon Sucrose Breath Test (13C-SBT) as a Marker of Environmental Enteropathy
Enrolling by invitation NCT03355313 - Use of Low-level Laser Therapy on Children Aged One to Five Years With Energy-protein Malnutrition N/A
Completed NCT04101487 - Cash Transfers to Increase Dietary Diversity in Grand Gedeh County, Liberia N/A
Active, not recruiting NCT05571280 - Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene. N/A
Withdrawn NCT05437068 - Nutritional Supplementation in Children at Risk of Undernutrition N/A
Recruiting NCT05442424 - Keiki (Pediatric) Produce Prescription (KPRx) Program Hawaii N/A
Completed NCT03454100 - Community Resilience to Acute Malnutrition N/A
Completed NCT04896996 - The Effect of Continuous Egg Supplement on Personalized Nutri-omics in Primary School Children (SI-EGG STUDY) N/A
Not yet recruiting NCT06049680 - Safety Study of SMOFlipid to Evaluate the Risk of Developing EFAD and/or PNAC in Pediatric and Adult Patients Phase 4
Recruiting NCT06382857 - Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition N/A
Recruiting NCT05269992 - Childrens Real Food Tolerance Study N/A
Active, not recruiting NCT05123378 - Liberia National Community Health Assistant (NCHA) Program and Under-five Mortality N/A
Completed NCT04688515 - Effectiveness of a Positive Deviance Program in Reducing Childhood Undernutrition N/A
Not yet recruiting NCT04810468 - Study of Malnutrition in Primary School Children N/A
Completed NCT04334538 - Effect of an Alternative RUTF on Intestinal Permeability in Children With Severe Acute Malnutrition N/A