[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658367":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":27,"studyPopulation":13,"armGroups":28,"interventions":40,"overallOfficials":13,"centralContacts":13,"locations":50,"responsibleParty":70,"collaborators":13,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":13,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":98,"whyStopped":13,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"International Centre for Diarrhoeal Disease Research, Bangladesh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"• Primary outcome: Clinical cure or Cessation of diarrhea","Clinical cure: \\\u003C3 liquid stools\u002F24 hours after randomization Cessation of diarrhea: passage of soft\u002Fformed or no stool for consecutive two 8-hour periods","Within 5 days from randomization",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Children will randomly receive either Green Banana (GB) mixed diet (n=52) or milk suji diet (n=52). The children, mothers\u002Fcaregivers and the research physician\u002Fother research staff will be blinded about the type of diet. The allocation of diet will be coded as \"A\" or \"B\" (any one for GB diet and the other for milk suji diet) with a block length of four by an independent scientist.","TREATMENT",{"masking":20,"maskingDescription":21,"whoMasked":22},"QUADRUPLE","Both A and B coded diets (GB and control) look almost similar as a thick, white, homogenous suspension, without substantial variation in test, color, and smell.",[23,24,25,26],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Objectives: The Primary objective is to determine if feeding boiled green banana (GB) added to Milk suji diet (GB-Milk Suji) compared to standard milk-based diet (Milk-suji), reduces the duration and severity of diarrhoeal illness; the Secondary objective is less frequent stool in children of 6-59 months of age with ProD.\n\nMethods: This will be Randomized double-blind clinical trial that will be conducted in the Dhaka Hospital of icddr,b. Children of age 6-59 month with history of diarrhea for 7-13 days will be enrolled. They will be randomly assigned to either GB-Milk suji diet (n=52) or milk suji diet (n=52) for 5 days. Stool output, consistency, frequency and clinical condition will be monitored daily. The participants will be discharged home after clinical improvement\u002Fcessation of diarrhea or switch over to other diet as per algorithm and other standard care practiced in the hospital if not recovered by end of day-5.\n\nOutcome measures\u002Fvariables:\n\n* Primary outcome: Clinical cure (\\\u003C3 liquid stools\u002F24 hours after randomization) or Cessation of diarrhea (passage of soft\u002Fformed or no stool for consecutive two 8-hour periods)\n* Secondary outcomes: i) Marked improvement (≤5 liquid stools\u002F24 hours by end of day-5); ii) Duration of diarrhea (last liquid stool after randomization) iii) Stool output; iv) Amount of IV and ORS needed.",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"Milk suji","EXPERIMENTAL","milk suji",[34],"Drug: MS",{"label":36,"type":31,"description":37,"interventionNames":38},"Arm MS +GB","milk + GB",[39],"Drug: MS +GB",[41,46],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":13},"DRUG","MS","Standard diet for the hospitallized children made with rice cereal, milk powder, soy bean oil and suger providing 67 kacl per 100 ml.",[30],{"type":42,"name":47,"description":48,"armGroupLabels":49,"otherNames":13},"MS +GB","Investigators will use the food items including green banana (Musa paradisiacal sapientum). Unripe, whole GB fruit will be cooked in boiling water and 200 gram (wet weight) of it will be used to make a total 1000 ml milk suji. The control group will receive milk suji (without any added green banana);the standard practice of study site (Dhaka Hospital, icddr,b)",[36],[51],{"facility":52,"status":13,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Dhaka Hospital, icddr,b","Dhaka","Dhaka Division","1212","Bangladesh","BD",{"type":59,"coordinates":60},"Point",[61,62],90.40744,23.7104,{"lat":62,"lon":61},[65],{"name":66,"role":67,"phone":68,"phoneExt":13,"email":69},"Shamima Sultana, MBBS, MPH","CONTACT","+8801715151404","shamima@icddrb.org",{"type":71,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100658367","phase-2-green-banana-added-diet-on-prolong-diarrhea-in-6-59-months-old-children-gb-in-prod-100658367",false,"NCT07848789","Green Banana Added Diet on Prolong Diarrhea in 6-59 Months Old Children (GB in ProD)","Randomized Double-blind Efficacy Trial of Green Banana Added Diet on Prolong Diarrhea in 6-59 Months Old Children","GB in ProD","Inclusion Criteria:\n\n* Age: \\> 6 to 59 months\n* Sex: Either\n* Duration of diarrhea: 7 to 13 days\n* Children able to take oral feeds at the time of randomization\n* Non-Severe Acute Malnutrition (SAM).\n* Not participating in another clinical study, the preceding 4 weeks\n* Parent willing to participate to the present study and providing informed written consent\n\nExclusion Criteria:\n\n* Children whose parents\u002Fcare givers do not provide consent\n* Children presented with severe pneumonia, septic shock, convulsion or any other illness that needs ICU support during the admission.\n* Birth defect like complex congenital heart diseases, cleft lip and cleft palate, Down syndrome and Cerebral palsy.\n* Children diagnosed as having apparent or known tuberculosis or HIV or PD (≥ 14 days)\u002Forganic diarrhea.","ALL","6 Months","59 Months",{"count":84,"type":85},104,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","The study likely to yield improved therapeutic modalities for children with prolonged diarrhea, a sequalae often leads to persistent diarrhea, which is linked to as much as 35% of diarrhea-associated deaths in children \\\u003C5 years of age. If found effective, the therapy would led to early recovery, reduce duration of hospitalization, intercurrent hospital infection and overall expenditure related to this illness.",[91,92],"Diarrhoeal Disease","Prolonged Diarrhea",[94,95,96,97],"Green banana","Milk suzi","children","prolonged diarrhea","NOT_YET_RECRUITING","2026-09-23",{"date":101,"type":102},"2026-09-30","ACTUAL",{"date":104,"type":85},"2026-09-13",{"date":106,"type":85},"2027-06-30",{"name":5,"class":6},1]