[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100604366":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":36,"locations":42,"responsibleParty":64,"collaborators":35,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":35,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":90,"overallStatus":45,"whyStopped":35,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Haiphong University of Medicine and Pharmacy","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"BioAmicus Complete + Usual Care","EXPERIMENTAL","Participants receive BioAmicus Complete (multistrain probiotic) oral drops in addition to usual care for infant functional GI symptoms. Product is administered by caregivers per protocol\u002Flabel for 42 days; adherence is recorded. No other probiotic products are permitted during the study. Concomitant medications and routine management are allowed at the investigator's discretion.",[13,14],"Dietary Supplement: BioAmicus Complete","Other: Usual Care (No Probiotic)",{"label":16,"type":17,"description":18,"interventionNames":19},"Usual Care Alone","ACTIVE_COMPARATOR","Participants receive standard clinical management per local practice for infant functional gastrointestinal symptoms. No probiotic supplementation is provided (participants are asked to avoid other probiotic products during the study). Concomitant medications and supportive care may be used as clinically indicated at the investigator's discretion.",[14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","BioAmicus Complete","Oral liquid probiotic (multistrain) administered by caregivers per protocol\u002Flabel for 42 days to infants with functional GI symptoms. Given as drops by mouth; dosing and administration instructions per protocol. No other probiotic products allowed during the study. Concomitant medications and routine management may be used as clinically indicated. Adherence is recorded; lot\u002Fbatch number captured.",[9],[27],"Multistrain Probiotic (BioAmicus Complete)",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Usual Care (No Probiotic)","Standard clinical management for infant functional gastrointestinal symptoms per local practice. No probiotic supplementation is provided during the study period. Participants follow the same visit and assessment schedule as the intervention arm. Concomitant medications and supportive care may be used as clinically indicated.",[9,16],[33,34],"Standard care","Routine clinical management",null,[37],{"name":38,"role":39,"phone":40,"phoneExt":35,"email":41},"Nguyen Thi Thu Phuong, MD, PhD","CONTACT","+84936685007","nttphuong@hpmu.edu.vn",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Clinical Trial and Bioequivalence Center","RECRUITING","Haiphong","Hai Phong","180000","Vietnam","VN",{"type":52,"coordinates":53},"Point",[54,55],106.68345,20.86481,{"lat":55,"lon":54},[58,62],{"name":59,"role":39,"phone":60,"phoneExt":35,"email":61},"Van Anh Tran, MSc.Pharm","0343035492","tvanh@hpmu.edu.vn",{"name":63,"role":39,"phone":35,"phoneExt":35,"email":41},"Phuong Thi Thu Nguyen, MD, PhD",{"type":65,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100604366","bioamicus-complete-for-functional-gastrointestinal-symptoms-in-infants-aged-0-to-24-months-100604366",false,"NCT07148583","BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months","Evaluation of the Efficacy and Safety of the Multistrain Probiotic \"BioAmicus Complete\" in Improving Gastrointestinal Symptoms in Children Aged 0-24 Months: A Randomized, Open-Label, Parallel-Group, Controlled Trial","CTBE2503","Inclusion Criteria:\n\n* Age 0-24 months at enrollment.\n* Infant has clinician-assessed functional gastrointestinal symptoms (e.g., colic\u002Firritability, regurgitation, constipation, loose stools), judged suitable for study participation.\n* Parent or legal guardian provides written informed consent and agrees to comply with study procedures (questionnaires\u002Fdiaries and sample collection, if applicable).\n* Caregivers agree to avoid other probiotic products during the study period, except as directed by the study team.\n\nExclusion Criteria:\n\n* Major congenital gastrointestinal anomalies or known chronic gastrointestinal diseases requiring ongoing prescription therapy (e.g., Hirschsprung disease, inflammatory bowel disease, short-bowel syndrome).\n* Clinically unstable condition or severe\u002Fcritical illness that could interfere with participation or safety in the opinion of the investigator.\n* Known or suspected primary or secondary immunodeficiency, or current immunosuppressive therapy.\n* History of severe allergy or hypersensitivity to components of the investigational product.\n* Recent use of systemic antibiotics within 14 days prior to baseline, or use of probiotic supplements within 14 days prior to baseline (per protocol).\n* Participation in another interventional clinical trial within 30 days prior to enrollment or during the study.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or confound outcome assessments.","ALL","0 Days","24 Months",{"count":78,"type":79},110,"ESTIMATED","INTERVENTIONAL",[82],"NA","Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome. This study evaluates whether the multistrain probiotic BioAmicus Complete can improve caregiver-reported gastrointestinal symptoms in infants 0-24 months and is safe for use in this population.\n\nThe primary assessment is the change in the Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score from the start to the end of the study period. Secondary assessments include symptom domains (colic\u002Fregurgitation, stool frequency and consistency), caregiver quality of life, growth parameters (weight and length), health care utilization and antibiotic exposure, and overall safety\u002Ftolerability (adverse events and serious adverse events). Stool samples will be analyzed to explore changes in the gut microbiome.",[85,86,87,88,89],"Infantile Colic","Gastroesophageal Reflux (GER)","Functional Constipation","Functional Diarrhea","Dysbiosis",[23,91,92,93,94,95,96,97],"probiotic","multistrain probiotic","infant","functional gastrointestinal symptoms","Infant Gastrointestinal Symptom Questionnaire","gut microbiome","stool microbiome","2026-01-28",{"date":100,"type":101},"2026-01-29","ACTUAL",{"date":103,"type":101},"2025-09-05",{"date":105,"type":79},"2026-05-30",{"name":5,"class":6},1]