[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539823":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":48,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":42,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":42,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":90,"whyStopped":42,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"International Centre for Diarrhoeal Disease Research, Bangladesh","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Microbiota Directed Food (MDF)","EXPERIMENTAL","Each participant will receive 12 weeks of MDF supplement. After finishing the intervention phase, he\u002Fshe will be followed-up for a 12-month period.",[13],"Dietary Supplement: Microbiota-Directed Food",{"label":15,"type":16,"description":17,"interventionNames":18},"Ready-to-Use Therapeutic Food (RUTF)","ACTIVE_COMPARATOR","Each participant will receive 12 weeks of RUTF supplement. After finishing the intervention phase, he\u002Fshe will be followed-up for a 12-month period.",[19],"Dietary Supplement: Ready-to-Use Therapeutic Food",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Microbiota-Directed Food","MDF is a microbiota directed food for malnourished children aged 6 months and above. It is in sachet form. The sachet contains 92 gm of supplements and provides approximately 506 kcal.",[9],[27],"MDF",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Ready-to-Use Therapeutic Food","RUTF is standard ready-to-use therapeutic food for SAM children aged 6 months and above.",[15],[33],"RUTF",[35],{"name":36,"affiliation":5,"role":37},"Md Hasan Hafizur Rahman, MPH, MBBS","PRINCIPAL_INVESTIGATOR",[39,44],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","01813333444",null,"hasan.hafizur@icddrb.org",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Ishita Mostafa, BDS, MPH","01755512359","ishita.mostafa@icddrb.org",[49],{"facility":50,"status":42,"city":51,"state":42,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Kurigram Study site","Kurigrām","Bangladesh","BD",{"type":55,"coordinates":56},"Point",[57,58],89.49354,23.1669,{"lat":58,"lon":57},[61],{"name":36,"role":40,"phone":41,"phoneExt":42,"email":43},{"type":63,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR",[65],{"name":66,"class":6},"Washington University School of Medicine","100539823","microbiota-directed-food-for-children-with-severe-acute-malnutrition-100539823",false,"NCT06308848","Microbiota Directed Food for Children With Severe Acute Malnutrition","Proof-of-Concept Study for a Microbiota-Directed Food in Children With Uncomplicated Severe Acute Malnutrition in Rural Bangladesh","Inclusion Criteria:\n\n* The trial will include SAM children of either sex without any medical complication\n* Children aged between 6-\\\u003C24 months and with MUAC \\\u003C115 mm and\u002For WLZ \\\u003C-3\n\nExclusion Criteria:\n\n* Children are not suffering from SAM.\n* Children with bi-pedal oedema.\n* Failed to obtain consent for study participation from parents or legal guardian.\n* Suffering from any chronic illness(es) or having severe anemia (\\\u003C 8 g\u002Fdl).\n* History of using antibiotics in the past seven days.\n* Children participating in other food intervention programs.\n* Children having known history of soy, peanut or milk protein allergy.\n* Children who will not pass appetite test.","ALL","6 Months","24 Months",{"count":78,"type":79},256,"ESTIMATED","INTERVENTIONAL",[82],"NA","Severe acute malnutrition (SAM) refers to a condition characterized by a significant deficit in weight-for-length measurements in children aged 6 to 59 months. It is a crucial public health concern with detrimental effects on child growth, development, and overall well-being. Addressing SAM is crucial to prevent its progression to other childhood morbidity and mortality and to ensure healthy child development. To meet the nutritional requirement of SAM children, icddr,b have come up with a novel intervention named microbiota-directed food (MDF), a ready-to-use therapeutic food. The investigators propose this proof-of-concept trial to establish evidence on the effect of this novel intervention on ponderal growth, microbial and proteomic recovery among the children with SAM in comparison to the standard RUTF.",[85],"Severe Acute Malnutrition",[87,88,89,52],"Microbiota directed food","SAM","Gut microbiota","NOT_YET_RECRUITING","2024-03-11",{"date":93,"type":94},"2024-03-13","ACTUAL",{"date":96,"type":79},"2024-04-15",{"date":98,"type":79},"2026-12-31",{"name":5,"class":6},1]