[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BioGaia AB\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,73],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100638747","influence-of-probiotics-on-early-gut-microbial-colonization-100638747",false,"NCT07608341","Influence of Probiotics on Early Gut Microbial Colonization","Influence of Probiotics on Early Gut Microbial Colonization, Safety and Tolerability in Infants Born by Caesarean Section","STORKIE","Inclusion Criteria:\n\nInfant born by planned C-section or vaginal born infant\n\nGestational age at birth ≥ 37±0 weeks to \\\u003C41 ±0 weeks\n\nInfant Apgar score 7-10, (5 minutes after birth)\n\nIntention to breastfeed the infant\n\nParents\u002Flegal guardians are \\>18 years\n\nParents\u002Flegal guardians have readiness and the opportunity to fill out a study diary, questionnaires and agree to collect biological samples\n\nParents\u002Flegal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator\n\nParents\u002Flegal guardians are willing and able to give written informed consent for their and their infants participation in the study\n\nExclusion Criteria:\n\n\\>72 hours after birth when collecting the first faecal sample and given the first drops of study product\n\nInfants classified as small for gestational age (SGA), defined as birth weight \\\u003C -2 standard deviations (SD) for gestational age and sex according to national reference standards.\n\nInfants with birth of congenital malformations or anomalies\n\nInfants not able to feed adequately by oral means at the time of screening (i.e., requiring tube feeding)\n\nInfants requiring care in neonatal unit\n\nDisruption of amniotic membranes for \\>24 hours\n\nInfants consuming probiotics, including in infant formula\n\nMothers use of antibiotics during the last 14 days of pregnancy prior to delivery\n\nParticipation in other clinical studies\n\nAny other disease, condition, or circumstance that, in the investigator's opinion, may compromise the participant's safety, adherence to the protocol, or the interpretation of study results",true,"ALL","0 Days","3 Days",{"count":22,"type":23},150,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this clinical trial is to learn whether daily probiotic drops plus vitamin D3 can improve early gut microbiome colonization in healthy infants born by C-section. It will also assess safety and tolerability.\n\nAn intervention with probiotics + vitamin D3 will be compared to placebo + vitamin D3 in a double-blind, randomized design, and include an open-label vaginal-born reference group.\n\nParticipants will receive study drops daily for 8 weeks and provide stool samples at multiple time points and complete questionnaires\u002Fdiaries. After the intervention period, there is an optional follow-up period for up to 3 years.",[29],"C-Section",[31,32,33,34],"microbiome","c-section","probiotic","gut microbiome","NOT_YET_RECRUITING","2026-05-19",{"date":38,"type":39},"2026-05-27","ACTUAL",{"date":41,"type":23},"2026-08-01",{"date":43,"type":23},"2030-08-01",{"name":45,"class":46},"BioGaia AB","INDUSTRY",2,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":18,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":24,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100607615","evaluating-the-effect-of-probiotic-limosilactobacillus-reuteri-l-reuteri-on-crying-and-fussing-time-in-infants-with-colic-100607615","NCT07190859","Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic","A Double-blind, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic","Inclusion Criteria:\n\n1. Aged between 3-12 weeks at screening.\n2. Gestational age 37+0 weeks - 42+0 weeks at birth.\n3. Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.\n4. Parents\u002Fcaregivers\u002Flegal guardians are \\>18 years.\n5. Exclusively or predominantly breastfed infants (\\> 50 % breast fed).\n6. Willing to maintain current feeding patterns (not change formula\u002Fnot change ratio of formula:breast milk etc.).\n7. Readiness and the opportunity for parents\u002Fcaregivers\u002Flegal guardians to fill out a study diary, questionnaires.\n8. Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents\u002Fcaregivers\u002Flegal guardians must report that their infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week). At Visit 2, this will be confirmed by Baby's Day Diary®, at least one 24-hour period should show 3 or more hours of crying\u002Ffussing time.\n9. Parents\u002Fcaregivers\u002Flegal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.\n10. Parents\u002Fcaregivers\u002Flegal guardians willing and able to give informed consent for their and their infant's participation in the study.\n11. The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 3 (Day 8), and Visit 4 (Day 22).\n12. Infant is considered healthy, in the opinion of the investigator following physical exam.\n\nExclusion Criteria:\n\n1. Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \\> 8 times daily, projectile, bilious or bloody emesis).\n2. Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container \\> 12x in breastfed and \\>5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents\u002Fcaregivers\u002F legal guardians.\n3. Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.\n4. Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.\n5. Infants with reported exposure to oral and\u002For systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.\n6. Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.","3 Weeks","12 Weeks",{"count":58,"type":23},50,[26],"This is a double-blind, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying and fussing time.",[62],"Infantile Colic","RECRUITING","2025-09-23",{"date":66,"type":39},"2025-09-24",{"date":68,"type":39},"2025-08-04",{"date":70,"type":23},"2026-08-30",{"name":45,"class":46},4,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":18,"minAge":55,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":24,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":47},"100478612","effect-of-probiotic-limosilactobacillus-reuteri-l-reuteri-on-crying-time-in-infants-with-colic-100478612","NCT05512234","Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic","A Double-blind, Mylti-center, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic","Inclusion Criteria:\n\n1. Aged between 3-8 weeks at screening.\n2. Gestational age 37+0 weeks - 42+0 weeks at birth.\n3. Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.\n4. Parents\u002Fcaregivers\u002Flegal guardians are \\>18 years.\n5. Exclusively or predominantly breastfed infants (\\> 50 % breast fed).\n6. Willing to maintain current feeding patterns (not change formula\u002Fnot change ratio of formula:breast milk etc.).\n7. Readiness and the opportunity for parents\u002Fcaregivers\u002Flegal guardians to fill out a study diary, questionnaires.\n8. Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents\u002Fcaregivers\u002Flegal guardians must report that their infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week). At Visit 2, this will be confirmed by Baby's Day Diary®, at least one 24-hour period should show 3 or more hours of crying\u002Ffussing time.\n9. Parents\u002Fcaregivers\u002Flegal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.\n10. Parents\u002Fcaregivers\u002Flegal guardians willing and able to give informed consent for their and their infant's participation in the study.\n11. The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 4 (Day 8), and Visit 6 (Day 22).\n12. Infant is considered healthy, in the opinion of the investigator following physical exam.\n\nExclusion criteria\n\n1. Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk \\> 8 times daily, projectile, bilious or bloody emesis).\n2. Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container \\> 12x in breastfed and \\>5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents\u002Fcaregivers\u002Flegal guardians.\n3. Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.\n4. Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.\n5. Infants with reported exposure to oral and\u002For systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.\n6. Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.","8 Weeks",{"count":82,"type":23},102,[26],"This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.",[86],"Colic, Infantile",[88,89],"Colic","L. reuteri","2025-09-17",{"date":92,"type":39},"2025-09-22",{"date":94,"type":39},"2022-07-13",{"date":96,"type":23},"2025-10-30",{"name":45,"class":46},""]