Using microbiome-directed foods to help children recover from malnutrition
Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition
This study is testing if special foods designed for gut health can help young children recover from malnutrition faster and stay healthy longer compared to regular nutritional therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 7356 (estimated) |
| Ages | 6 Months to 23 Months |
| Sex | All |
| Sponsor | Epicentre Academic / other |
| Locations | 1 site (Maradi) |
| Trial ID | NCT06382857 on ClinicalTrials.gov |
What this trial studies
This study is an individually randomized controlled trial that compares the effectiveness of microbiome-directed foods to standard nutritional therapy for children aged 6 to less than 24 months suffering from uncomplicated acute malnutrition. The primary focus is on achieving programmatic recovery within 12 weeks of admission and ensuring sustained recovery at 24 weeks. The study will assess recovery rates based on specific nutritional metrics, including mid-upper arm circumference (MUAC) and weight-for-length z-scores (WLZ). Participants will receive either microbiome-directed foods or standard ready-to-use therapeutic foods.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to less than 24 months diagnosed with uncomplicated acute malnutrition, either severe or moderate.
Not a fit: Patients with medical complications requiring inpatient treatment or those with known allergies to the study interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve nutritional recovery outcomes for malnourished children.
How similar studies have performed: Other studies have shown promise in using microbiome-directed approaches for nutritional recovery, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Maradi
- Epicentre Niger — Maradi, Niger (Recruiting)
Study contacts
- Study coordinator: Sheila Isanaka, ScD
- Email: sisanaka@hsph.harvard.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.