An interventional study of MDF and RUTF in Malnutrition, Child, sponsored by Epicentre. Recruiting at 1 site in Niger. Open to participants aged 6 Months to 23 Months. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Epicentre · Not applicable, Interventional, and Treatment
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.
167 studies on the registry are indexed under Child Nutrition Disorders; 36 are open to participants now.
This study's planned enrollment of 7,356 is above the median of 402 across 132 interventional studies indexed under Child Nutrition Disorders.
Browse Child Nutrition Disorders studies →Epicentre is the lead sponsor of 49 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The MDF in this study was developed by the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,B). This MDF is the lead icddr,B prototype that has demonstrated the strongest increase in biomarkers critical to growth, including growth hormone receptor and leptin, and re-establishment of the maturity of the microbiome among moderately malnourished children. Ingredients include chickpea flour, soy flour, peanut paste, green banana powder, sugar, oil, and micronutrients. The same MDF is provided for the treatment of SAM and MAM at modified doses.
Dietary Supplement: MDF
The standard RUTF used in this study for the treatment of SAM is Plumpy'Nut (Nutriset France). RUTF is a specialized therapeutic food that can be consumed without preparation and meets the nutritional requirements for the recovery of SAM. Ingredients include oil, peanut, skimmed milk powder, sugar and micronutrients. The standard RUSF used in this study is Plumpy'Sup (Nutriset France). RUSF is a lipid-based nutritional supplement with a high vitamin and mineral content, specifically designed for the treatment of MAM. Ingredients include oil, peanut, skimmed milk powder, sugar and micronutrients.
Dietary Supplement: RUTF · Dietary Supplement: RUSF
MDF will be provided to children on a weekly basis for children with SAM and bi-weekly basis for children with MAM at the health center until programmatic recovery but not thereafter.
RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter
Also known as: Standard RUTF
RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter
Also known as: Standard RUSF
Programmatic recovery by 12 weeks from admission
Defined as the proportion of SAM and MAM children achieving a WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema during 2 consecutive visits
Time frame: 12 weeks
Sustained recovery at 24 weeks from admission
Proportion of recovered SAM and MAM children with WLZ ≥ -2 AND MUAC ≥ 125mm AND no edema
Time frame: 24 weeks
Default
Defined as 2 consecutive missed scheduled program visits
Time frame: 12 weeks
Non-response
Defined as WLZ \< -2 or MUAC \< 125 mm during 2 consecutive visits, or for SAM children only: persistent edema at 12 weeks
Time frame: 12 weeks
Time to recovery
Measured as days from admission to programmatic recovery among recovered children
Time frame: 12 weeks
For MAM children: Deterioration to SAM
Weight-for-height z-score (WHZ) inferior to -3
Time frame: 24 weeks
Change in weight gain
Change in g/kg/day
Time frame: From enrollment to 4, 8 and 12 weeks
Change in weight-for-length Z (WLZ)
Change in WLZ calculated using the 2006 WHO Growth Standards
Time frame: From enrollment to 4, 8 and 12 weeks
Change in length-for-age Z (LAZ)
Change in LAZ calculated using the 2006 WHO Growth Standards
Time frame: From enrollment to 4, 8 and 12 weeks
Change in weight-for-age Z (WAZ)
Change in WAZ calculated using the 2006 WHO Growth Standards
Time frame: From enrollment to 4, 8 and 12 weeks
Change in MUAC
Change in mm
Time frame: From enrollment to 4, 8 and 12 weeks
Serious adverse events
Combined safety endpoint, including hospitalization and death
Time frame: 24 weeks
Hospitalization
Inpatient stay \> 24h
Time frame: 24 weeks
Death
All-cause mortality
Time frame: 24 weeks
Motor, cognitive, language, social-emotional, and mental health skills
As measured by the Caregiver Reported Early Development Instrument (CREDI)
Time frame: 24 weeks
Cost effectiveness
As defined by the incremental cost per child recovered and per child sustained recovered
Time frame: 24 weeks
Dietary intake
As measured by 24h recall
Time frame: 24 weeks
Adherence
Defined as the sum of sachets returned used divided by the total number of sachets distributed
Time frame: 12 weeks
Microbiome profile at enrollment, week 4, program discharge, and study discharge
Defined as PCR-confirmed enteric viral, bacterial, and protozoan pathogens present
Time frame: 24 weeks
Plasma proteome profile at enrollment, week 4, program discharge, and study discharge
Defined as circulating plasma proteins (IGFBP-2, thrombospondin-5, granulysin, GDF-15, and MMP-8)
Time frame: 24 weeks
Environmental enteric dysfunction at enrollment, program discharge, and study discharge
Measured by anti-LPS IgA and IgG; anti-flagellin IgA and IgG; sCD14; I-FABP; myeloperoxidase (MPO); and calprotectin
Time frame: 24 weeks
Change of fat mass and fat-free mass at program discharge and study discharge
Measured by deuterium dilution
Time frame: 24 weeks
Micronutrient status at enrollment, program discharge and study discharge
Defined as ferritin; soluble transferrin binding protein; alpha-tocopherol; retinol; folate; and vitamin B12
Time frame: 24 weeks
Immuno-sufficiency at week 2, week 4, program discharge, week 12 and study discharge (SAM only)
As defined by T-cell receptor excision circles (TRECs) and kappa-receptor excision circles (KRECs)
Time frame: 24 weeks
Plan to share: No
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