[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545511":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":49,"responsibleParty":69,"collaborators":74,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":27,"eligibilityCriteria":89,"healthyVolunteers":86,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":27,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":52,"whyStopped":27,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Epicentre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Microbiome directed food (MDF)","EXPERIMENTAL","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.",[13],"Dietary Supplement: MDF",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard nutritional treatment (RUTF\u002FRUSF)","ACTIVE_COMPARATOR","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.",[19,20],"Dietary Supplement: RUTF","Dietary Supplement: RUSF",[22,28,34],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIETARY_SUPPLEMENT","MDF","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.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"RUTF","RUTF will be provided to all children on a weekly basis at the health center until programmatic recovery but not thereafter",[15],[33],"Standard RUTF",{"type":23,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"RUSF","RUSF will be provided on a biweekly basis at the health center until programmatic recovery but not thereafter",[15],[39],"Standard RUSF",[41],{"name":42,"affiliation":5,"role":43},"Rebecca Grais, PhD","STUDY_CHAIR",[45],{"name":46,"role":47,"phone":27,"phoneExt":27,"email":48},"Sheila Isanaka, ScD","CONTACT","sisanaka@hsph.harvard.edu",[50],{"facility":51,"status":52,"city":53,"state":27,"zip":27,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Epicentre Niger","RECRUITING","Maradi","Niger","NE",{"type":57,"coordinates":58},"Point",[59,60],7.10174,13.5,{"lat":60,"lon":59},[63,66],{"name":64,"role":47,"phone":27,"phoneExt":27,"email":65},"Ousmane Guindo, MD","ousmane.guindo@epicentre.msf.org",{"name":67,"role":47,"phone":27,"phoneExt":27,"email":68},"Ibrahim Ngoumboute, MD","ibrahim.ngoumboute@epicentre.msf.org",{"type":70,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":73,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Sheila Isanaka","Associate Professor","Harvard School of Public Health (HSPH)",[75,78,80,82],{"name":76,"class":77},"Epicentre, Niger","UNKNOWN",{"name":79,"class":77},"National Nutrition Direction, Niger",{"name":81,"class":77},"Ministry of Public Health and Social Affairs, Niger",{"name":83,"class":77},"Regional Direction of Public Health, Maradi","100545511","effectiveness-of-a-microbiome-directed-food-to-promote-programmatic-and-sustained-nutritional-recovery-among-children-with-uncomplicated-acute-malnutrition-100545511",false,"NCT06382857","Effectiveness of a Microbiome-directed Food to Promote Programmatic and Sustained Nutritional Recovery Among Children With Uncomplicated Acute Malnutrition","Inclusion Criteria:\n\n* for children with Severe Acute Malnutrition (SAM): MUAC \\\u003C 115 mm and\u002For WLZ \\\u003C -3 and\u002For mild (+) or moderate (++) edema\n* for children with Moderate Acute Malnutrition (MAM): 115 mm ≤ MUAC \\\u003C 125 mm and\u002For -3 ≤ WHZ \\\u003C -2\n* Caregiver providing informed consent\n\nExclusion Criteria:\n\n* Medical complications requiring inpatient treatment, as identified by the national protocol\n* Not eating\u002Flack of appetite (as informed by appetite test and investigator judgement)\n* Re-admission into the program within 2 months of previous default\n* for children with Severe Acute Malnutrition (SAM): Referral from inpatient care (therapeutic feeding center, TFC) or supplementary feeding program (SFP)\n* for children with Moderate Acute Malnutrition (MAM): Referral from SAM treatment (TFC or OTP)\n* Presence of congenital abnormality or underlying chronic disease that may affect growth or risk of infection\n* Known contraindication\u002F hypersensitivity\u002Fallergy to study interventions (chickpea\u002Fsoy flour, banana, peanut)\n* Residence outside the study catchment area or in a non-fixed (e.g. nomadic) community","ALL","6 Months","23 Months",{"count":94,"type":95},7356,"ESTIMATED","INTERVENTIONAL",[98],"NA","This study is an individually randomized controlled trial comparing microbiome-directed foods to standard nutritional therapy among children aged 6 to \\\u003C 24 months with uncomplicated acute malnutrition in terms of programmatic recovery by 12 weeks from admission and sustained recovery at 24 weeks from admission.",[101],"Malnutrition, Child",[103,104,105,106,24,107],"Malnutrition","SAM","MAM","Child","Microbiome","2024-08-26",{"date":110,"type":111},"2024-08-27","ACTUAL",{"date":113,"type":111},"2024-05-02",{"date":115,"type":95},"2026-02-01",{"name":5,"class":6},1]