Actively Recruiting
Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
Led by Epicentre · Updated on 2024-08-27
7356
Participants Needed
1
Research Sites
91 weeks
Total Duration
On this page
Sponsors
E
Epicentre
Lead Sponsor
E
Epicentre, Niger
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \< 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.
CONDITIONS
Official Title
Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 6 to less than 24 months
- Severe Acute Malnutrition (SAM) defined by MUAC < 115 mm and/or WLZ < -3 and/or mild (+) or moderate (++) edema
- Moderate Acute Malnutrition (MAM) defined by 115 mm 64 MUAC < 125 mm and/or -3 64 WHZ < -2
- Caregiver provides informed consent
You will not qualify if you...
- Medical complications requiring inpatient treatment as per national protocol
- Lack of appetite or not eating as judged by appetite test and investigator
- Re-admission into the program within 2 months of previous default
- Referral from inpatient care or supplementary feeding program for SAM cases
- Referral from SAM treatment for MAM cases
- Presence of congenital abnormalities or chronic diseases affecting growth or infection risk
- Known allergy to chickpea, soy flour, banana, or peanut
- Residence outside study catchment area or living in non-fixed communities (e.g., nomadic)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Epicentre Niger
Maradi, Niger
Actively Recruiting
Research Team
S
Sheila Isanaka, ScD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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