Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition

Launched by EPICENTRE · Apr 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how effective a special type of food, designed to support the gut bacteria (known as the microbiome), is for helping young children recover from malnutrition. The trial is focusing on children aged 6 to 24 months who are experiencing uncomplicated acute malnutrition. Researchers want to see if these microbiome-directed foods can help children recover better compared to standard nutrition methods after 12 weeks, and maintain that recovery by 24 weeks.

To participate, children need to meet certain criteria. They should have either severe or moderate acute malnutrition, which is determined by specific measurements and signs, such as weight and nutritional status. Caregivers must be able to provide consent for their child to take part. Those with serious medical issues, lack of appetite, or certain allergies will not be eligible. If a child joins the study, they will receive either the special food or standard nutritional therapy and will be monitored over several weeks to track their recovery progress. This study aims to find better ways to help malnourished children thrive.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • for children with Severe Acute Malnutrition (SAM): MUAC \< 115 mm and/or WLZ \< -3 and/or mild (+) or moderate (++) edema
• • for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC \< 125 mm and/or -3 ≤ WHZ \< -2
• • Caregiver providing informed consent
• Exclusion Criteria:
• • Medical complications requiring inpatient treatment, as identified by the national protocol
• • Not eating/lack of appetite (as informed by appetite test and investigator judgement)
• • Re-admission into the program within 2 months of previous default
• • for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)
• • for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)
• • Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection
• • Known contraindication/ hypersensitivity/allergy to study interventions (chickpea/soy flour, banana, peanut)
• • Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community