[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100472484":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":29,"locations":35,"responsibleParty":66,"collaborators":68,"id":72,"slug":26,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"The Archer-Daniels-Midland Company","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active","EXPERIMENTAL","Arm receiving investigation product (probiotic)",[13],"Dietary Supplement: Probiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Arm receiving placebo",[19],"Dietary Supplement: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Probiotic","Single strain probiotic in a form of a sachets with a daily dose of 1.0E+9 Colony Forming Unit (CFU) per day for 4 weeks",[9],null,{"type":22,"name":15,"description":15,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},"ADM Medical Team","CONTACT","+44 1460 243 230","medical@protexin.com",[36,49],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":26},"Atlantia Food Clinical Trials","COMPLETED","Chicago","Illinois","60611","United States",{"type":44,"coordinates":45},"Point",[46,47],-87.65005,41.85003,{"lat":47,"lon":46},{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Pulse Multispeciality Hospital,","RECRUITING","Pune","Maharashtra","Pune 411 041","India",{"type":44,"coordinates":57},[58,59],73.85535,18.51957,{"lat":59,"lon":58},[62],{"name":63,"role":32,"phone":64,"phoneExt":26,"email":65},"Mr. Deepak Bagade","9970004295","dbagade66@gmail.com",{"type":67,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[69,70],{"name":37,"class":6},{"name":71,"class":6},"Vedic Lifesciences Pvt. Ltd.","100472484",false,"NCT05432479","Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief","A Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief","PIXAR","Inclusion Criteria:\n\n* Gestational age of minimum 37 weeks.\n* Birthweight of minimum 2500 g (5.5 lb.).\n* Age of greater than 3 weeks and less than 12 weeks at enrolment.\n* Confirmed Infantile colic defined as: parental report of crying and\u002For fussing ≥3 hours\u002Fday for ≥3 days\u002Fweek, confirmed prior to enrolment with an infant behaviour diary recording \\>3 hours of crying in a 24-hour period (eDiary App completed daily during run-in period \\& for duration of study).\n* Participant Informed Consent form signed by parent or legal guardian.\n* Infant is considered healthy following physical exam.\n* Parents\u002FCaregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits\n\nExclusion Criteria:\n\n* Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial.\n* Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics).\n* Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).\n* Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract.\n* Failure to thrive.\n* Known lactose or gluten intolerance.\n* Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo.\n* Known other causes for abdominal pain (e.g., pyloric stenosis).\n* Participation in any other interventional clinical study.\n* Immuno-compromised participant or participant with other severe chronic disorder.\n* Use of probiotic supplements by breastfeeding mother from child's birth to enrolment.\n* Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial.\n* Any Participant\u002FParent\u002FCaregiver who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.","ALL","3 Weeks","12 Weeks",{"count":83,"type":84},80,"ESTIMATED","INTERVENTIONAL",[87],"NA","This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.",[90],"Infantile Colic",[92,93,94,95],"probiotic","Bifidobacterium","colic","cry","2025-04-08",{"date":98,"type":99},"2025-04-09","ACTUAL",{"date":101,"type":99},"2022-09-30",{"date":103,"type":84},"2026-05",{"name":5,"class":6},2]