[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484292":3},{"organization":4,"outcomesModule":7,"designInfo":51,"detailedDescription":59,"studyPopulation":56,"armGroups":60,"interventions":82,"overallOfficials":105,"centralContacts":110,"locations":119,"responsibleParty":144,"collaborators":147,"id":153,"slug":56,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":154,"sex":160,"minAge":161,"maxAge":162,"enrollmentInfo":163,"targetDuration":56,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":56,"overallStatus":172,"whyStopped":56,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":182},{"fullName":5,"class":6},"Institut de Recherche en Sciences de la Sante, Burkina Faso","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":46},[9,13],{"measure":10,"description":11,"timeFrame":12},"Programmatic recovery defined by Weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm","Moderate cute malnutrition is defined by Weight-for-height (WHZ) \\\u003C - 2 z-score or mid-upper arm circumference (MUAC) \\\u003C 125 mm. Higher WHZ z-score (≥ - 2) or mid-upper arm circumference (MUAC) ≥ 125 mm means better outcome synonym of recovery","12th weeks from admission to the supplementation program",{"measure":14,"description":15,"timeFrame":16},"Sustained recovery defined by WHZ ≥ - 2 z-score or MUAC ≥ 125 mm","Children who sustain recovery (WHZ ≥ - 2 z-score or MUAC ≥ 125 mm) up to 24 weeks","24 weeks from admission to the supplementation program",[18,22,25,28,32,36,39,43],{"measure":19,"description":20,"timeFrame":21},"Mean change in Weight-for-height (WHZ) z-score","(WHZ z-score at admission) - (WHZ z-score at 12 weeks)","12 weeks from admission to the supplementation program",{"measure":23,"description":24,"timeFrame":21},"Mean change in Weight-for-age (WAZ) z-score","(WAZ z-score at admission) - (WAZ z-score at 12 weeks)",{"measure":26,"description":27,"timeFrame":21},"Mean change in Height-for-age (HAZ) z-score","(HAZ z-score at admission) - (HAZ z-score at 12 weeks)",{"measure":29,"description":30,"timeFrame":31},"Time to recovery","Determined by the number of days from admission to programmatic recovery among those who recovered","Up to 12 weeks",{"measure":33,"description":34,"timeFrame":35},"Dropouts","Lost to follow up","12 weeks",{"measure":37,"description":38,"timeFrame":35},"Non-response defined by WHZ \u003C -2 z-score, or a MUAC \u003C 125 mm","Children who failed to attain a weight-for-height (WHZ) ≥ - 2 z-score or mid-upper arm circumference (MUAC) ≥ 125 mm",{"measure":40,"description":41,"timeFrame":42},"Complications","* Edema\n* Fever \\>39°C or hypothermia \\\u003C35°C\n* Severe dehydration\n* Repeated or incessant vomiting\n* Severe respiratory problem (IMCI criteria)\n* severe anemia (significant pallor with difficulty of breathing)\n* Severe malaria\n* Abscess or extensive skin lesions\n* Very weak, apathetic, unconscious\n* Seizure","up to 12 weeks",{"measure":44,"description":45,"timeFrame":42},"Failure","Absence of weight gain, assessed at the 3rd consecutive visit;\n\n* Weight loss since admission to the program, assessed at the 1st visit after admission;\n* Loss of 5% of body weight compared to admission weight.",[47],{"measure":48,"description":49,"timeFrame":50},"Cost-effectiveness","Cost-effectiveness, as defined by the incremental cost per child cured according to the program and per child cured sustainedly","12 weeks; 24 weeks",{"allocation":52,"interventionModel":53,"interventionModelDescription":54,"primaryPurpose":55,"observationalModel":56,"timePerspective":56,"maskingInfo":57},"RANDOMIZED","PARALLEL","Individually randomized and controlled trial,\n\nStratified by severity of malnutrition:\n\n* 2 arms for Severe Acute malnutrition\n* 2 arms for Moderate acute Malnutrition","TREATMENT",null,{"masking":58,"maskingDescription":56,"whoMasked":56},"NONE","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.\n\nThe 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.\n\nFollow-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.\n\nAt each visit, anthropometric measurements will be performed; a morbidity questionnaire will be administered before the mother\u002Fcaregiver receives the ration for the following period. For the measurement of adherence, mothers will be asked to bring back empty and unused sachets\u002Fpackaging of supplements from the last visit. Questions will also be asked to the mother\u002Fcaregiver on the difficulties encountered during consumption and the adverse events observed following the consumption of the supplements.",[61,67,72,77],{"label":62,"type":63,"description":64,"interventionNames":65},"Microbiome-directed food (MDF) - MAM","EXPERIMENTAL","Each (MAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks",[66],"Dietary Supplement: Microbiome-directed food - MAM",{"label":68,"type":69,"description":64,"interventionNames":70},"Ready-to-use supplementary food (RUSF)","ACTIVE_COMPARATOR",[71],"Dietary Supplement: Ready-to-use supplementary food (RUSF)",{"label":73,"type":63,"description":74,"interventionNames":75},"Microbiome-directed food (MDF) - SAM","Each (SAM) child will receive a daily ration of MDF corresponding to his weight, for maximum 12 weeks of supplementation.",[76],"Dietary Supplement: Microbiome-directed food (MDF) - SAM",{"label":78,"type":69,"description":79,"interventionNames":80},"Ready-to-use therapeutic food (RUTF)","Each (SAM) child will receive a daily ration of RUTF corresponding to his weight, for maximum 12 weeks of supplementation",[81],"Dietary Supplement: Ready-to-use therapeutic food (RUTF)",[83,90,95,100],{"type":84,"name":85,"description":86,"armGroupLabels":87,"otherNames":88},"DIETARY_SUPPLEMENT","Microbiome-directed food - MAM","Each MAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.",[62],[89],"MDF - MAM",{"type":84,"name":68,"description":91,"armGroupLabels":92,"otherNames":93},"Each MAM child will be supplemented with RUSF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.",[68],[94],"RUSF",{"type":84,"name":73,"description":96,"armGroupLabels":97,"otherNames":98},"Each SAM child will be supplemented with MDF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.",[73],[99],"MDF - SAM",{"type":84,"name":78,"description":101,"armGroupLabels":102,"otherNames":103},"Each SAM child will be supplemented with RUTF for a maximum of 12 weeks. He will be followed subsequently up to 24 weeks.",[78],[104],"RUTF",[106],{"name":107,"affiliation":108,"role":109},"Seni KOUANDA, MD., PhD","Institut de Recherche en Sciences de la Santé, Burkina-Faso","PRINCIPAL_INVESTIGATOR",[111,116],{"name":112,"role":113,"phone":114,"phoneExt":56,"email":115},"Hermann Biènou LANOU, MD., PhD.","CONTACT","+226 66557580","hlanou@yahoo.ca",{"name":107,"role":113,"phone":117,"phoneExt":56,"email":118},"+226 70261462","senikouanda@gmail.com",[120],{"facility":121,"status":56,"city":122,"state":123,"zip":56,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"LANOU Hermann Bienou","Ouagadougou","Kadiogo","Burkina Faso","BF",{"type":127,"coordinates":128},"Point",[129,130],-1.53388,12.36566,{"lat":130,"lon":129},[133,135,137,140,142],{"name":134,"role":113,"phone":114,"phoneExt":56,"email":115},"Hermann Biènou LANOU, MD., PhD",{"name":136,"role":113,"phone":117,"phoneExt":56,"email":118},"Seni KOUANDA, MD.,PhD",{"name":138,"role":139,"phone":56,"phoneExt":56,"email":56},"Hermann LANOU, PhD.","SUB_INVESTIGATOR",{"name":141,"role":139,"phone":56,"phoneExt":56,"email":56},"Jérôme SOME, PhD",{"name":143,"role":109,"phone":56,"phoneExt":56,"email":56},"Seni KOUANDA, PhD",{"type":109,"investigatorFullName":145,"investigatorTitle":146,"investigatorAffiliation":5,"oldNameTitle":56,"oldOrganization":56},"Hermann Lanou","Principal Investigator",[148,150],{"name":149,"class":6},"Ministry of Health, Burkina Faso",{"name":151,"class":152},"Bill and Melinda Gates Foundation","OTHER","100484292",false,"NCT05586139","Microbiome-Directed Food for Sustained Recovery From Acute Malnutrition","Efficacy of a Food Targeting the Microbiota for a Sustained Recovery of Children With Uncomplicated Acute Malnutrition","MDF","Inclusion Criteria:\n\n* Age between 6 and 23 months\n* Moderate wasting: WHZ \\\u003C -2 and ≥ -3 or MUAC \\\u003C 125 mm and ≥ 115mm or - Severe wasting: WHZ \\\u003C -3 or MUAC \\\u003C 115 mm\n\nExclusion Criteria:\n\n* Bilateral pitting edema\n* Not eating\u002Flack of appetite\n* Current illness medical complications requiring inpatient treatment\n* Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection\n* Known contraindication\u002Fhypersensitivity\u002Fallergy to MDCF of RUSF ingredients (chickpea flour, soy flour, banana, peanut)\n* Relapse from MAM treatment or transfer from SAM treatment\n* Children recently (\\\u003C2 months) or enrolled in a nutrition program\n* Residence outside the study area","ALL","6 Months","23 Months",{"count":164,"type":165},6200,"ESTIMATED","INTERVENTIONAL",[168],"NA","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:\n\n* Does treating children with moderate or severe uncomplicated malnutrition using MDF leads to higher programmatic recovery rate compared to standard of care ?\n* 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.",[171],"Acute Malnutrition With no Complications","NOT_YET_RECRUITING","2024-03-12",{"date":175,"type":176},"2024-03-13","ACTUAL",{"date":178,"type":165},"2024-10",{"date":180,"type":165},"2026-12",{"name":5,"class":6},1]