Clinical trial Recruiting at 1 site Interventional Ages 6 Months to 59 Months

Alternative feeding protocol for acute malnutrition in young children

Official title: Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition in Children Aged 6-59 Months in Burkina Faso: Reduced Dose of RUTF for SAM Children and RUTF Instead of RUSF for MAM Children

Run by Institut de Recherche en Sciences de la Sante, Burkina Faso · NCT06792370 · Data updated 2026-11-12

This study tests whether using ready-to-use food instead of standard foods, and lowering the amount of therapy for severe cases, can still help children recover from acute malnutrition.

Quick facts

Study typeInterventional
Ages6 Months to 59 Months
SexAll
Enrollment3521 (estimated)
SponsorInstitut de Recherche en Sciences de la Sante, Burkina Faso
Government
Locations1 site (Ouagadougou, KADIOGO)
StatusRecruiting
StartedNovember 26, 2025
Main results expectedNovember 2027
Study endsNovember 2027
Registry record updatedOctober 23, 2026
Trial IDNCT06792370 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 6-59 months with MAM or SAM without complications who can attend regular follow-up visits.

Probably not a fit

Children with medical complications, allergies to key ingredients, or residence outside the study area may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In Burkina Faso, children aged 6-59 months with acute malnutrition are randomized to three groups for moderate malnutrition (MAM) and two groups for severe malnutrition (SAM) to compare alternative RUTF/RUSF feeding strategies. The trial follows up to 12 weeks of supplementation with weekly or biweekly visits, plus monthly post-programme follow-up to assess sustained recovery and other outcomes. Outcomes include programmatic recovery, cost-effectiveness, psychomotor development in a subsample, weight and height changes, and relapse incidence. Adherence and safety are monitored through caregiver reports and routine measurements.

Why it matters

Potential benefit: If successful, the protocol could simplify treatment, potentially reduce costs, and maintain recovery and growth in children with acute malnutrition.

How similar studies have gone: Previous nutrition trials have explored Ready-to-Use Foods and dose adjustments, with mixed but promising results for non-inferiority in recovery.

Who can join: the full rules

Show full inclusion / exclusion criteria
1. MAM

   Inclusion Criteria:
   * Anthropometric measures:

     * (115 mm ≤ MUAC\< 125 mm and -3 SDs ≤ WLZ \< -2 SDs) OR
     * (115 mm ≤ MUAC\< 125 mm and WLZ ≥ -2 SDs) OR
     * (MUAC ≥ 125 mm and -3 SDs ≤ WLZ \< -2 SDs).
   * Age: 6 to 59 months
   * Parents' acceptance of biweekly visits until programme discharge and monthly visits for the post-programme follow up

   Exclusion Criteria:
   * Failure of appetite test
   * Medical complications requiring hospital treatment
   * Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection
   * Presence of bilateral oedema
   * History of allergies to peanuts, milk, or soya
   * Relapse from MAM treatment or transfer from SAM treatment
   * Children who have recently (\<2 months) taken part in a nutrition programme;
   * Residence outside the study area
   * Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)
2. SAM

Inclusion Criteria:

* Anthropometric measures MUAC\< 115 mm or WLZ\< - 3 SDs;
* Age: 6-59 months;
* Parents' acceptance of weekly visits until programme discharge and monthly visits for the post-programme follow up.

Exclusion Criteria:

* Failure of appetite test
* Medical complications requiring hospital treatment
* Presence of any congenital anomaly or underlying chronic disease that may affect growth or the risk of infection
* Presence of bilateral oedema
* History of allergies to peanuts, milk or soya
* Relapse from MAM treatment or transfer from SAM treatment
* Children who have recently (\<2 months) taken part in a nutrition programme;
* Residence outside the study area;
* Mother or caregivers deemed unable to comply with the necessary requirements of the study (particular medical condition of the mother or caregivers, etc.)

Where it's running

  • Institut de Recherche en Sciences de la Santé
    Ouagadougou, Kadiogo, Burkina Faso
    Recruiting

Study contacts

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.