[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colic-infantile\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colic-infantile":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100478612","effect-of-probiotic-limosilactobacillus-reuteri-l-reuteri-on-crying-time-in-infants-with-colic-100478612",false,"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.","ALL","3 Weeks","8 Weeks",{"count":20,"type":21},102,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27],"Colic, Infantile",[29,30],"Colic","L. reuteri","RECRUITING","2025-09-17",{"date":34,"type":35},"2025-09-22","ACTUAL",{"date":37,"type":35},"2022-07-13",{"date":39,"type":21},"2025-10-30",{"name":41,"class":42},"BioGaia AB","INDUSTRY",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":51,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100602250","validation-of-a-parent-administered-symptom-score-for-unsettled-infants-every-baby-is-unique-100602250","NCT07121062","Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)","Validation Of A Parent Administered Symptom Score For Unsettled Infants","Inclusion Criteria:\n\n1. Consent to complete the anonymous questionnaire\n2. Parent 18 years old or over\n3. Parent of an infant aged under 12 months old at time of questionnaire completion\n\nExclusion Criteria:\n\n1. Parent does not consent to complete the anonymous questionnaire\n2. Parent under 18 years old\n3. Parent of an infant aged 12 months or older at time of questionnaire completion",true,"18 Years",{"count":54,"type":21},350,"OBSERVATIONAL","It's common for infants to be unsettled, especially in the first few months of life. While this is often normal, persistent symptoms can be stressful for families. Parents naturally seek explanations, and common suspected causes include colic, reflux, eczema, and cow's milk allergy (CMA). However, CMA is frequently over diagnosed, which can lead to unnecessary changes such as stopping breastfeeding or switching to expensive specialist formulas.\n\nTo address this, we've developed an online questionnaire to help track and understand symptoms in unsettled infants. Our long-term goal is to use this tool to support more accurate diagnosis of CMA. Before that, we need to test and validate the questionnaire in a general population of infants, including those who are healthy and those with other temporary conditions like a recent immunisation or teething.\n\nThis study involves an anonymous online survey for parents of babies under 12 months old. We aim to collect data from approximately 350 participants. The study will help us assess how well the questionnaire reflects the severity of symptoms and whether it can distinguish between healthy infants and those with underlying issues.\n\nParents will be invited to take part using flyers with a QR code distributed in various healthcare settings, including GP clinics and children's clinics in hospital. The survey is anonymous and hosted on a secure platform. While we don't anticipate the questions to be distressing, we recognise some may touch on sensitive topics. Support resources and study team contact details will be provided.\n\nBy validating this tool, we hope to improve how unsettled behaviour in infants is assessed-reducing unnecessary interventions and better supporting families and healthcare professionals.",[27,58,59,60,61,62],"Milk Allergy, Cow's","Gastro Oesophageal Reflux Disease","Atopic Dermatitis (Eczema)","Constipation - Functional","Congential Hip Dysplasia",[64,65,66],"Infantile colic","Cows milk allergy","Unsettled behaviour","NOT_YET_RECRUITING","2025-08-06",{"date":70,"type":35},"2025-08-13",{"date":72,"type":21},"2025-09",{"date":74,"type":21},"2026-08",{"name":76,"class":77},"University Hospital Southampton NHS Foundation Trust","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":78},"100518475","prevalence-and-natural-history-of-functional-gastrointestinal-disorders-among-at-risk-infants-100518475","NCT06031025","Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.","Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants","FUSID","Inclusion Criteria:\n\n* infants with gestational age at birth \\\u003C 31 weeks\n* infants with gestational age at birth \\\u003C 37 weeks and major respiratory or neurologic morbidity\n* infants with history of perinatal asphyxia\n\nExclusion Criteria:\n\n* lack of informed consent\n* diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)","3 Months","24 Months",{"count":90,"type":21},71,"The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are:\n\n* evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life\n* describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.",[93,94,61,95,96,27,97],"Functional Gastrointestinal Disorders","Gastroesophageal Reflux","Diarrhea","Dyschezia","Vomiting; Cyclical","2025-03-10",{"date":100,"type":35},"2025-03-11",{"date":102,"type":35},"2022-05-20",{"date":104,"type":21},"2025-09-30",{"name":106,"class":77},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]