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
13 weeks
Total Duration
On this page
Sponsors
E
Epicentre
Lead Sponsor
E
Epicentre, Niger
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a microbiome-directed food (MDF) compared to standard nutritional therapy for children aged 6 to less than 24 months who have uncomplicated acute malnutrition. The study aims to assess how well children recover programmatically by 12 weeks after starting treatment and maintain that recovery at 24 weeks. This trial focuses on improving growth and health outcomes in children with moderate or severe acute malnutrition. The study compares two main treatments: the experimental microbiome-directed food developed by the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,B), and the standard nutritional foods used for treatment. The MDF includes ingredients like chickpea flour, soy flour, peanut paste, green banana powder, sugar, oil, and micronutrients, provided weekly for severe cases and biweekly for moderate cases until recovery. The standard therapy uses ready-to-use therapeutic foods (RUTF) and supplements (RUSF) with similar nutritional components, given on a weekly or biweekly basis depending on malnutrition severity. Participants will be monitored from enrollment through 24 weeks, with assessments including weight gain, growth measurements, motor and cognitive skills, dietary intake, and microbiome and plasma profiles. Recovery and sustained health status will be tracked at specific intervals, including program discharge and final study discharge. Safety will be monitored by recording serious adverse events, hospitalizations, and deaths. Adherence to treatments and cost-effectiveness will also be evaluated during the study period.
CONDITIONS
Brief 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
- For Severe Acute Malnutrition (SAM): MUAC less than 115 mm and/or weight-for-length Z score less than -3 and/or mild or moderate edema
- For Moderate Acute Malnutrition (MAM): MUAC between 115 mm and less than 125 mm and/or weight-for-length Z score between -3 and -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 test and investigator
- Re-admission into the program within 2 months after previous default
- For SAM: Referral from inpatient care or supplementary feeding program
- For MAM: Referral from SAM treatment programs
- Presence of congenital abnormalities or chronic diseases affecting growth or infection risk
- Known allergy or hypersensitivity to study ingredients (chickpea, soy flour, banana, peanut)
- Residence outside study area or in non-fixed communities such as nomadic groups
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks until programmatic recovery
Participants receive microbiome-directed food or standard nutritional treatment on a weekly or biweekly basis at the health center until programmatic recovery.
Weekly or biweekly visits at the health center depending on treatment and malnutrition severity
Duration - Up to 24 weeks from admission
Participants are monitored for sustained recovery and other health outcomes after the treatment ends.
Periodic visits up to 24 weeks from admission
Trial Site Locations
Total: 1 location
1
Epicentre Niger
Maradi, Niger
Actively Recruiting
Research Team
S
Sheila Isanaka, ScD
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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