[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infantile-colic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infantile-colic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,55,80,107,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"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":21,"type":22},110,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31,32],"Infantile Colic","Gastroesophageal Reflux (GER)","Functional Constipation","Functional Diarrhea","Dysbiosis",[34,35,36,37,38,39,40,41],"BioAmicus Complete","probiotic","multistrain probiotic","infant","functional gastrointestinal symptoms","Infant Gastrointestinal Symptom Questionnaire","gut microbiome","stool microbiome","RECRUITING","2026-01-28",{"date":45,"type":46},"2026-01-29","ACTUAL",{"date":48,"type":46},"2025-09-05",{"date":50,"type":22},"2026-05-30",{"name":52,"class":53},"Haiphong University of Medicine and Pharmacy","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"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":65,"type":22},50,[25],"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.",[28],"2025-09-23",{"date":71,"type":46},"2025-09-24",{"date":73,"type":46},"2025-08-04",{"date":75,"type":22},"2026-08-30",{"name":77,"class":78},"BioGaia AB","INDUSTRY",4,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":88,"targetDuration":4,"studyType":23,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":106},"100472484","study-to-evaluate-the-efficacy-of-a-probiotic-in-infantile-colic-symptoms-relief-100472484","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.",{"count":89,"type":22},80,[25],"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.",[28],[35,94,95,96],"Bifidobacterium","colic","cry","2025-04-08",{"date":99,"type":46},"2025-04-09",{"date":101,"type":46},"2022-09-30",{"date":103,"type":22},"2026-05",{"name":105,"class":78},"The Archer-Daniels-Midland Company",2,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":113,"sex":17,"minAge":18,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":120,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":4},"100573260","0-3-months-infantile-colic-the-effect-of-ocean-sound-on-babies-100573260","NCT06743971","0-3 Months Infantile Colic The Effect of Ocean Sound on Babies","Inclusion Criteria:\n\n* Volunteering to participate in the study\n* Diagnosis of infantile colic according to Wessel criteria\n* The baby is born prematurely\u002Fmaturely\n* The baby is between 0-3 months\n* Babies must have passed the newborn hearing screening test (the sound level used during the test is set at 30 decibels)\n* Otoscopic examinations of babies should be performed by a specialist physician\n* The baby has no diagnosis other than infantile colic on examination\n* The baby does not have any chronic disease\n* Mothers know how to read, write and speak Turkish\n* No alternative application (massage, oil, herbal teas, etc.) should be used before the application\n\nExclusion Criteria:\n\n* The baby has any acute and chronic disease\n* The baby has a congenital anomaly\n* The mother has diagnosed mental and psychological problems\n* Diagnosis of lactose intolerance in infants by a physician\n* Previously diagnosed with Infantile Colic and continuing medical treatment\n* Babies have not passed the newborn hearing screening test\n* Otoscopic examinations of infants not performed by a specialist physician",true,"3 Months",{"count":116,"type":22},60,[25],"Infant colic is one of the most common health problems in newborns and infants. It is a syndrome of unknown cause, occurring in attacks, weakened by clenched fists, hardening of the abdomen, flatulence, pulling the legs to the abdomen, very difficult to stop and excessive crying. Various studies have been conducted on this subject and the incidence rates in healthy babies vary between 10-40%. Significant behavioral problems may arise in sleep, rest and feeding due to frequent and prolonged periods of arrest, which are considered to be the upper point of normal crying. In these mothers, symptoms such as helplessness, fatigue, insomnia, exhaustion, loss of life, feelings of inadequacy, anxiety and crying problems may occur. In these mothers, variability is also extended. While in the womb, the fetus is attuned to the sound of the blood in the mother's arteries and the rocking motion of her abdomen. During infancy, the uterus is constantly hearing sounds at a higher frequency than a vacuum cleaner and these sounds stimulate a calming reflex in the baby. Our aim in this study was to investigate the sound of the ocean in infants with infantile colic aged 0-3 months.",[28],[121,122,96,123],"pediatric nurse","infantil colic","sleep","NOT_YET_RECRUITING","2024-12-16",{"date":127,"type":46},"2024-12-20",{"date":129,"type":22},"2024-12-15",{"date":131,"type":22},"2025-01-30",{"name":133,"class":53},"Zonguldak Bulent Ecevit University",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":164},"100545680","phase-2-effect-of-probiotics-on-infantile-colic-symptoms-100545680","NCT06385054","Effect of Probiotics on Infantile Colic Symptoms","Effect of Probiotics on Infantile Colic Symptoms: a Randomized, Double-blind, Placebo-controlled Study (EPIC).","EPIC","Inclusion Criteria:\n\nI1. Healthy male or female. I2. Age ≤ 8 weeks old. I3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behavior for 3 or more hours per day, during 3 or more days in 7 days.\n\nI4. Exclusively breastfeeding and planning to breastfeed for the duration of the study.\n\nI5. With a written informed consent signed by the father and mother or legal guardian.\n\nI6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and scheduled telephone calls.\n\nI7. At least one of the legal representatives is affiliated with a social security scheme.\n\nExclusion Criteria:\n\nE1. Birthweight \\\u003C 2500 g. E2. Gestational age \\\u003C 37 weeks. E3. Apgar score at 5 minutes \\\u003C 7. E4. Partially or fully formula fed infants except for the 4 first days after birth.\n\nE5. Stunted growth\u002Fweight loss (\\\u003C 100 g\u002Fweek from birth to last reported). E6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or gastrointestinal malformations.\n\nE7. Diagnosed or reported fever and\u002For infectious diseases, or current systemic infections, or history of congenital infections.\n\nE8. Genetic diseases and chromosomal abnormalities. E9. Metabolic diseases or pancreatic insufficiency. E10. Immunodeficiency. E11. Neurological diseases. E12. Suspected or confirmed food allergies and intolerances. E13. Mother who consumed antacid medications (proton pump inhibitor and H2 receptor antagonist) within the month before birth and intend to consume any during the trial.\n\nE14. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening and during the trial.\n\nE15. Use of anti-colic medication at any time from birth to the moment of screening.\n\nE16. Use of probiotics and prebiotics supplements by the mother between the birth of their infant and the moment of screening and intend to consume any during the trial.\n\nE17. Currently enrolled in another clinical study or having participated in another clinical from birth to the moment of screening.\n\nE18. Whose legal representatives have psychological or linguistic incapability to sign the informed consent.\n\nE19. Impossibility to contact the legal representatives in case of emergency.","8 Weeks",{"count":144,"type":22},70,[146],"PHASE2","The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.",[28],[140,150,151,152,153,154],"Infant Colic","Probiotics","Crying Time","Gut Microbiota","Sleep Duration","2024-08-14",{"date":157,"type":46},"2024-08-16",{"date":159,"type":22},"2024-08",{"date":161,"type":22},"2027-02",{"name":163,"class":78},"Lallemand Health Solutions",10]