NCT Number: NCT05586139
The goal of this experimental study is to test the efficacy of a new formulation - The microbiome-directed food (MDF) to treat acute malnutrition among children aged 6 to 23 months. The main questions are:
* Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher programmatic recovery rate compared to standard of care ? * Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher sustained recovery rate compared to standard of care ? The MDF will be compared to Ready-to-use supplementary food (RUSF) for moderately malnourished children, and to Ready-to-use therapeutic food (RUTF) for severely malnourished children to see the effects on recovery and sustained recovery rate.
Trial opening soon.
Get Notified6 month–23 month
All sexes
Interventional
Not applicable
Ouagadougou, Kadiogo, Burkina Faso
Hermann Biènou LANOU, MD., PhD
CONTACT
Hermann LANOU, PhD.
SUB_INVESTIGATOR
Jérôme SOME, PhD
SUB_INVESTIGATOR
Seni KOUANDA, MD.,PhD
CONTACT
Seni KOUANDA, PhD
PRINCIPAL_INVESTIGATOR
In this stratified trial, children presenting at the health center and fulfilling the inclusion criteria will be randomly allocated into one of the study groups in a ratio of 1:1:1 for MAM and 1:1 for SAM.
The supplementation will be done on daily basis according to the child's weight for a maximum of 12 weeks, at which point the programmatic recovery assessment is done. Those who recovered before or at this point, will be subsequently followed up monthly up to 3 month for sustained recovery assessment.
Follow-up visits will be done at the health center every week for severe acute malnutrition (SAM) children and every two weeks for moderate acute malnutrition (SAM) children.
At each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother/caregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets/packaging of supplements from the last visit. Questions will also be asked to the mother/caregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Each MAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Other names: MDF - MAM
Each MAM child will be supplemented with RUSF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Other names: RUSF
Each SAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Other names: MDF - SAM
Each SAM child will be supplemented with RUTF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.
Other names: RUTF
Time frame: 12th weeks from admission to the supplementation program
Moderate cute malnutrition is defined by Weight-for-height (WHZ) < - 2 z-score or mid-upper arm circumference (MUAC) < 125 mm. Higher WHZ z-score (≥ - 2) or mid-upper arm circumference (MUAC) ≥ 125 mm means better outcome synonym of recovery
Time frame: 24 weeks from admission to the supplementation program
Children who sustain recovery (WHZ ≥ - 2 z-score or MUAC ≥ 125 mm) up to 24 weeks
Time frame: 12 weeks from admission to the supplementation program
(WHZ z-score at admission) - (WHZ z-score at 12 weeks)
Time frame: 12 weeks from admission to the supplementation program
(WAZ z-score at admission) - (WAZ z-score at 12 weeks)
Time frame: 12 weeks from admission to the supplementation program
(HAZ z-score at admission) - (HAZ z-score at 12 weeks)
Time frame: Up to 12 weeks
Determined by the number of days from admission to programmatic recovery among those who recovered
Time frame: 12 weeks
Lost to follow up
Time frame: 12 weeks
Children who failed to attain a weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm
Time frame: up to 12 weeks
Time frame: up to 12 weeks
Absence of weight gain, assessed at the 3rd consecutive visit;
Time frame: 12 weeks; 24 weeks
Cost-effectiveness, as defined by the incremental cost per child cured according to the program and per child cured sustainedly
Contact information is provided by the study sponsor or research team.
Hermann Biènou LANOU, MD., PhD.
CONTACT
Seni KOUANDA, MD., PhD
CONTACT
Institut de Recherche en Sciences de la Sante, Burkina Faso
Other Gov
Efficacy of a Food Targeting the Microbiota for a Sustained Recovery of Children With Uncomplicated Acute Malnutrition
Acronym: MDF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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