[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100367533":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":23,"locations":36,"responsibleParty":49,"collaborators":51,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":23,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":76,"whyStopped":23,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Ferrer Internacional S.A.","INDUSTRY",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Gelatin tannate (GT)","EXPERIMENTAL",[12],"Combination Product: Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation",{"label":14,"type":15,"description":14,"interventionNames":16},"Placebo","PLACEBO_COMPARATOR",[17],"Combination Product: placebo + ORS + Zinc supplementation",[19,24],{"type":20,"name":21,"description":21,"armGroupLabels":22,"otherNames":23},"COMBINATION_PRODUCT","Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation",[9],null,{"type":20,"name":25,"description":25,"armGroupLabels":26,"otherNames":23},"placebo + ORS + Zinc supplementation",[14],[28,32],{"name":29,"affiliation":30,"role":31},"Aldiouma Diallo, MS","IRD Senegal (Niakhar Center IRD BP 1386 Hann Mariste, CP 18524 Dakar. Sénégal.","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":35},"Javier Xllop","Noventure SL","STUDY_DIRECTOR",[37],{"facility":38,"status":23,"city":39,"state":23,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":23},"Niakhar Center IRD","Dakar","18524","Senegal","SN",{"type":44,"coordinates":45},"Point",[46,47],-17.44406,14.6937,{"lat":47,"lon":46},{"type":50,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[52],{"name":53,"class":6},"Axonal-Biostatem","100367533","phase-3-clinical-trial-in-children-between-3-months-and-14-years-old-to-evaluate-the-efficacy-and-safety-of-gelatin-tannate-in-the-treatment-of-acute-diarrhea-indigo-100367533",false,"NCT04065529","Clinical Trial in Children Between 3 Months and 14 Years Old to Evaluate the Efficacy and Safety of Gelatin Tannate in the Treatment of Acute Diarrhea (INDIGO)","Efficacite et Innocuite du Tannate de Gelatine Dans le Traitement de la Diarrhee aiguë de l'Enfant. Une Etude Randomisee, Controlee, en Double Aveugle (INDIGO)","INDIGO","Inclusion Criteria:\n\n* AGE defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form (BSF) scale ≥ 6 or, the Brussels Infant and Toddler Stool Scale (BITSS) =4 in the case of infants ≤ 3 years (see Annex 1) and\u002For an increase in the frequency of evacuations (typically ≥3 in 24 h),\n* AGE lasting between 1 day and 2 days;\n* Children from 3 months old\n* Children up to 14 years old;\n* Written informed consent form signed by parents or legal guardians must be provided to caregivers.\n* Subject willing and able to comply with study restrictions and willing to return to the health center and to perform the follow-up evaluation as specified in the protocol.\n\nExclusion Criteria:\n\n* Use of antibiotics, diosmectite, probiotics, racecadotril, loperamide or zinc (including zinc containing ORS) within a week prior to enrolment\n* Chronic diarrheal gastrointestinal disease (e.g, inflammatory bowel diseases, cystic fibrosis, coeliac disease, food allergy)\n* Immunodeficiencies\n* Signs of malnutrition according to the opinion of the investigator (weight\u002Fheight under 3rd z score as per World Health Organization \\[WHO\\] Child Growth Standards)\n* Need for Intravenous rehydration\n* Subject who previously entered in a clinical study within the past 30 days.\n* Pregnancy and suspected Pregnancy","ALL","3 Months","14 Years",{"count":66,"type":67},150,"ACTUAL","INTERVENTIONAL",[70],"PHASE3","To evaluate the safety, global efficacy and rapidity of action of GT in children with acute gastroenteritis taking ORS solution.",[73],"Diarrhea",[75],"Diarrhea; gastroenterology; acute gastroenteritis; gastroenteritis; acute; gelatin; tannate","COMPLETED","2020-11-03",{"date":79,"type":67},"2020-11-04",{"date":81,"type":67},"2019-09-11",{"date":83,"type":67},"2020-06-11",{"name":5,"class":6},1]