[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556851":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":41,"responsibleParty":43,"collaborators":45,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":41,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":41,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":67,"overallStatus":74,"whyStopped":41,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":41},{"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","EXPERIMENTAL","Children randomized to this group will receive Microbiota-directed food (MDF) daily for 12 weeks. MDF can modulate the gut microbiota and enhance host immunity, growth, and development in malnourished children.",[13],"Dietary Supplement: Microbiota-directed food",{"label":15,"type":16,"description":17,"interventionNames":18},"Khichuri","ACTIVE_COMPARATOR","Children randomized to this group will receive zinc with Micronutrient powder (MNP) and Khichuri daily for 12 weeks.",[19],"Dietary Supplement: Khichuri",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","MDF can modulate the gut microbiota and enhance host immunity, growth, and development in malnourished children. Each sachet of MDF (100 gm) provides approximately 500 kcal.",[9],[26],"MDF",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Khichuri is a home-based nutritious food with high energy and protein. This arm also contains zinc (10 gm\u002Fday), micronutrient powder, and an egg daily.",[15],[31],"Locally available food",[33],{"name":34,"affiliation":5,"role":35},"Farzana Afroze","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Farzana Afroze, MBBS, FCPS","CONTACT","+8801722363067",null,"farzana9afroze9@gmail.com",{"type":44,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR",[46],{"name":47,"class":6},"Washington University School of Medicine","100556851","post-discharge-trial-to-enhance-immunity-in-severely-malnourished-children-100556851",false,"NCT06530485","Post Discharge Trial to Enhance Immunity in Severely Malnourished Children","Enhancing Immunity and Nutrition in Severely Malnourished Children Following Hospital Discharge: a Two Arm Open-label Randomized Controlled Trial of Microbiota-Directed Food vs. Zinc With Micronutrient Powder and Khichuri","Inclusion Criteria:\n\n* Children aged 6 months to 36 months, and\n* Severe acute malnutrition as evident by weight-for-length z-score (WLZ) \\\u003C -3 and or mid-upper arm circumference (MUAC) \\\u003C 11.5 cm, and or edema of both feet, and\n* Completed the acute phase management for SAM and stayed at NRU for 7±4 days, with no medical complications, e.g. lethargic\u002Funconscious, convulsions, unable to drink, persistent vomiting, respiratory distress.\n* Residing within the Dhaka district.\n* Parents\u002Fguardians provided written informed consent.\n\nExclusion Criteria:\n\n* WLZ ≥ -3 or MUAC ≥11.5 cm.\n* Presence of lethargy\u002Funconsciousness, convulsions, unable to drink, persistent vomiting, respiratory distress.\n* Participants who receive multiple courses of antibiotic (\\>2 courses during acute phase) treatment for a prolonged period (\\>14 days).\n* Persistent diarrhea (≥14 days).\n* Chronic illness or disability affecting food intake, e.g. TB, HIV, congenital defects, cerebral palsy\n* Treated for SAM in the previous 3 months.\n* Known case of soy, peanut, or milk protein allergy.\n* Any sibling of the enrolled child.","ALL","6 Months","36 Months",{"count":59,"type":60},150,"ESTIMATED","INTERVENTIONAL",[63],"NA","The goal of this study is to evaluate the efficacy of microbiota-directed food in comparison to zinc with micronutrient powder and Khichuri on changes in circulating immune cells (monocytes, T cells, B cells, and NK cells) in malnourished children after recovery from acute infection.\n\nThe study aims to answer the research question:\n\nDoes microbiota-directed food (MDF) compared to zinc with micronutrient powder (MNP) and Khichuri therapy enhance immunity in children with severe acute malnutrition? The researcher will compare the effectiveness of microbiota-directed food (MDF) versus zinc with micronutrient powder (MNP) and Khichuri therapy to see if MDF enhances immunity in severely malnourished children.\n\nSeverely malnourished children will:\n\n* Receive microbiota-directed food (MDF) or zinc with micronutrient powder (MNP) and Khichuri every day for 12 weeks.\n* Phenotyping of circulating immune cells (NK cells, T cells, B cells) will be conducted using flow cytometry and fluorescence-activated cell sorting techniques.",[66],"Child Malnutrition",[68,69,70,71,72,73],"Immunity","Malnutrition","Microbiota-directed food (MDF)","Zinc","NK cells","Gut microbiota","NOT_YET_RECRUITING","2024-07-31",{"date":77,"type":78},"2024-08-02","ACTUAL",{"date":80,"type":60},"2024-08-01",{"date":82,"type":60},"2025-12-31",{"name":5,"class":6}]