[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"healthy-infants\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:healthy-infants":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,42,65,95,129,157,185,212,247,269],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100640328","growth-tolerance-and-functional-biomarkers-in-healthy-infants-receiving-dietary-supplements-100640328",false,"NCT07630584","Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements","Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements: A Double-blind, Randomized Placebo-controlled Nutritional Study","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \\[LAR\\])\n2. Parent(s) \u002F LAR(s) must be able to provide evidence of parental authority and identity\n3. Parent(s) \u002F LAR(s) must understand the informed consent form and other study documents\n4. Parent(s) \u002F LAR(s) are willing and able to comply with scheduled visits and the requirements of the study protocol\n5. Parent(s) \u002F LAR(s) can be contacted directly by telephone throughout the study\n6. Parent(s) \u002F LAR(s) must be able to temporarily store stool samples in a household freezer\n7. Infants may be exclusively breastfed, exclusively formula-fed, or mixed fed with both breast milk and infant formula in any proportion. Parent(s) \u002F LAR(s) must intend to maintain the infant's current mode of feeding until the end of the study period:\n\n   1. For exclusively breastfed infants: parents must intend to continue exclusive breastfeeding. As defined by the World Health Organization, exclusive breastfeeding means that the infant receives only breast milk. No other liquids or solids are given (not even water) with the exception of oral rehydration solution, or drops\u002Fsyrups of vitamins, minerals, or medicines.\n   2. For formula-fed infants (either exclusively or mixed-fed): parent(s) \u002F LAR(s) must intend to maintain the infant's current mode of feeding, plus:\n\n      * Parents \u002F LAR(s) must have previously and independently decided to use formula\n      * Infant must be consuming and tolerating a standard cow's milk infant formula not containing probiotics at the time of enrollment\n8. Infant must be healthy based on medical history and physical examination\n9. Infant full-term gestational birth (born 37 weeks, 0 days through 41 weeks, 6 days of gestation)\n10. Infant singleton birth\n11. Infant postnatal age ≥ 14 and ≤ 28 days (date of birth = day 0)\n12. Infant birth weight is appropriate for gestational age (≥ 2500 and ≤ 4500 grams)\n\nExclusion Criteria:\n\n1. Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol\n2. Infants who have a medical condition or medical history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:\n\n   1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation)\n   2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)\n   3. Previous or ongoing antibiotic usage by the infant, except when given for prophylactic reasons (e.g., erythromycin ophthalmic ointment)\n   4. Immunocompromised infants and those who have a central venous catheter\n   5. History of admission to the Neonatal Intensive Care Unit, except for admission for jaundice phototherapy\n   6. Known or suspected allergy to milk (including lactose) or soy\n   7. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgement of the investigator, would make the infant inappropriate for entry into the study\n3. Infants who are currently receiving or who have received any probiotic supplements or infant formula containing probiotics prior to enrollment\n4. Infants who are currently receiving or who have received any of the following medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and\u002For metabolism (e.g., pancreatic enzymes), stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose), growth (e.g. insulin or growth hormone), microbiome-related endpoints (e.g., prebiotic supplements), or gastric acid secretion\n5. Infants whose parent(s) \u002F LAR(s) have not reached the legal age of majority (18 years old)\n6. Infants who are currently or who previously participated in another interventional clinical study\n7. Parent(s) \u002F LAR(s) with family or hierarchical relationships with the research team members",true,"ALL","14 Days","28 Days",{"count":21,"type":22},327,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is a double-blind, randomized, placebo-controlled nutritional study aimed at investigating growth, tolerance, and functional biomarkers in healthy infants receiving dietary supplements from birth to 2.5 months of age",[28],"Healthy Infants",[30],"Dietary Supplement","NOT_YET_RECRUITING","2026-06-01",{"date":34,"type":35},"2026-06-05","ACTUAL",{"date":32,"type":22},{"date":38,"type":22},"2028-08-31",{"name":40,"class":41},"Société des Produits Nestlé (SPN)","INDUSTRY",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100619196","efficacy-of-a-dietary-supplement-in-infants-100619196","NCT07341477","Efficacy of a Dietary Supplement in Infants","Microbiome and Health-related Effects of a Dietary Supplement in Infants: a Double-blind, Randomized, Placebo-controlled Nutritional Study.","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \\[LAR\\])\n2. Parent(s) \u002F LAR(s) must be able to provide evidence of parental authority and identity\n3. Parent(s) \u002F LAR(s) must understand the informed consent form and other study documents\n4. Parent(s) \u002F LAR(s) are willing and able to comply with scheduled visits and the requirements of the study protocol including infant blood collection\n5. Parent(s) \u002F LAR(s) can be contacted directly by telephone throughout the study\n6. Parent(s) \u002F LAR(s) must be able to temporarily store stool samples in a household freezer\n7. Parent(s) \u002F LAR(s) of formula-fed infants (either exclusively or mixed-fed) must have previously and independently decided to use formula and their infant must be consuming and tolerating a standard cow's milk infant formula not containing probiotics at the time of enrollment\n8. Infant must be healthy based on medical history and physical examination\n9. Infant full-term gestational birth (born 37 weeks, 0 days through 41 weeks, 6 days)\n10. Infant age 5 months ± 1 week (date of birth = day 0) at time of clinic visit 1\n11. Infant birth weight is appropriate for gestational age (i.e., ≥ 2500 and ≤ 4500 grams)\n\nExclusion Criteria:\n\n1. Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol\n2. Infants receiving solid foods or liquids other than breastmilk or infant formula within 4 weeks prior to enrollment\n3. Infants who have a medical condition or medical history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:\n\n   1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation)\n   2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)\n   3. Immunocompromised infants and those who have a central venous catheter\n   4. History of admission to the Neonatal Intensive Care Unit, except for admission for jaundice phototherapy.\n   5. Known or suspected allergy to milk (including lactose) or soy\n   6. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgement of the investigator, would make the infant inappropriate for entry into the study.\n4. Infants who are currently receiving or who have received any probiotic supplements or any infant formula containing probiotics prior to enrollment\n5. Infants who are currently receiving or who have previously received any of the following medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and\u002For metabolism (e.g., pancreatic enzymes), stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose), growth (e.g. insulin or growth hormone), microbiome-related endpoints (e.g., prebiotic supplements, antibiotic usage within the past 4 weeks \\[not including topical or ophthalmic applications\\]), or gastric acid secretion.\n6. Infants whose parent(s) \u002F LAR(s) have not reached the legal age of majority (18 years old)\n7. Infants who are currently or who previously participated in another interventional clinical study\n8. Parent(s) \u002F LAR(s) with family or hierarchical relationships with the research team members","19 Weeks","21 Weeks",{"count":52,"type":22},172,[25],"This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants. The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement.",[28],[30],"2026-04-23",{"date":59,"type":35},"2026-04-24",{"date":61,"type":22},"2026-06",{"date":63,"type":22},"2027-12",{"name":40,"class":41},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":16,"sex":17,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":23,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100631795","an-intervention-study-in-healthy-infants-aged-0-6-months-with-probiotics-lacticaseibacillus-rhamnosus-lra05-lra05-and-bifidobacterium-animalis-subsp-lactis-bla80-bla80-vs-placebo-for-promoting-gut-microbiome-development-100631795","NCT07505329","An Intervention Study in Healthy Infants Aged 0-6 Months With Probiotics Lacticaseibacillus Rhamnosus LRa05 (LRa05) and Bifidobacterium Animalis Subsp. Lactis BLa80 (BLa80) vs. Placebo, for Promoting Gut Microbiome Development.","SMILE","Inclusion criteria Written (electronic) informed consent provided by parent to allow their infant to participate in the study.\n\nNo antibiotic use since birth. Infant not to be taking any medications. Infant not to be taking probiotics. Breastfed or formula fed until weaning. Infants born via c-section or vaginally. Healthy male and female infants.\n\nExclusion criteria Infant is older than 3 months at the time their first study visit (Baseline visit).\n\nInfants who have a known diagnosis of inflammatory bowel disease or another medical condition.\n\nInfants with complex medical or behavioural needs that would deem the infant unable to participate in the study.\n\nHave a significant acute or chronic co-existing illness (cardiovascular, gastrointestinal, endocrinological, immunological, metabolic) or any condition which contraindicates entry to the study according to the investigator's judgement.\n\nInfants who are receiving treatment involving experimental medications. Have a malignant disease or any concomitant end-stage organ disease. Infants born before 37 weeks of pregnancy.","1 Month","3 Months",{"count":75,"type":22},300,[25],"The probiotics Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa05 have potential to enhance infant health and development based on previous research conducted on human infants.\n\nBifidobacterium animalis subsp. lactis BLa80 was isolated from healthy breast milk samples.\n\nTen clinical studies have been conducted using this strain, including randomized, double-blind, placebo-controlled trials, involving over 700 clinical subjects, adults and children. Based on the results from these studies, functional benefits associated with ingestion of this probiotic include relief of diarrhea, relief of constipation, improved sleep quality, resistance to H. pylori infection, modulation of gut microbiota, promotion of infant growth and development, gestational diabetes management and emotional management.\n\nLacticaseibacillus rhamnosus LRa05 was isolated from healthy baby faeces. Six clinical studies have been conducted, involving randomized, double-blind, placebo-controlled studies using this strain, involving over 500 clinical subjects. Based on the results from these studies, functional benefits associated with ingestion of this probiotic include relief of diarrhea, relief of eczema, resistance to H. pylori infection, modulation of gut microbiota, promotion of infant growth and development, and gestational diabetes management.\n\nThis proposal describes a three-year collaboration with APC Microbiome Ireland, INFANT Research Centre and WeCare to conduct clinical studies to investigate the effects of probiotics (Bifidobacterium animalis subsp. lactis BLa80 and Lacticaseibacillus rhamnosus LRa050), compared to a placebo, on the growth of infants and toddlers and the development of their gut microbiota. The focus of this study is on infant growth and gut microbiota development in infants up to 6 months old.",[79,28],"Less Than 3 Months Old",[81,82,83],"Gut microbiome","Oral probiotics","Healthy infants","2026-03-26",{"date":86,"type":35},"2026-04-01",{"date":88,"type":22},"2026-04",{"date":90,"type":22},"2028-03",{"name":92,"class":93},"University College Cork","OTHER",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":16,"sex":17,"minAge":103,"maxAge":18,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":94},"100619678","preventive-effect-of-a-dietary-supplement-with-two-probiotic-limosilactobacillus-reuteri-strains-on-excessive-crying-and-colic-in-healthy-newborns-100619678","NCT07347743","Preventive Effect of a Dietary Supplement With Two Probiotic Limosilactobacillus Reuteri Strains on Excessive Crying and Colic in Healthy Newborns.","Double-blind, Randomized Placebo-controlled Trial for the Preventive Effect of Limosilactobacillus Reuteri (L. Reuteri) on Excessive Crying and Colic in Healthy Infants.","ProtectPrevent","Inclusion Criteria:\n\n1. Infant is born at the maternity ward of UZ Brussel with a gestational age of ≥37 weeks.\n2. Infant is healthy at the time of pre-examination.\n3. Infant is aged between 1 and 14 days old at the time of inclusion.\n4. Legal guardian(s) are able and willing to follow the study instructions\n5. Infant is suitable for participation in the study according to the investigator\u002F study personnel\n6. Legal guardian(s) willing to refrain products containing probiotics for their infant, from baseline (visit 1) throughout the study period (visit 3).\n7. Informed written consent given by parent \u002F legal guardian\n\nExclusion Criteria:\n\n1. No legal guardian's command of any local language\n2. Infant with a major congenital anomaly (i.e. anal atresia, trisomy 21) or suspicion of any chronic disorder or disease (i.e. Hirschsprung's disease, metabolic disorder)\n3. Infant is suffering from congenital or acquired immunodeficiency\n4. Infant is suffering from an infection at the time of pre-examination or previous 7 days\n5. Infant is admitted post-partum to the neonatal intensive care unit\n6. Infant is not suitable for participation in the study according to the study personnel´s opinion","1 Day",{"count":105,"type":22},768,[25],"This study aims to demonstrate that a dietary supplement, which contains two strains of the probiotic L. reuteri is safe, well tolerated and able to reduce the incidence of colic and excessive crying\u002Ffussiness in healthy infants. Additionally, the study aims to investigate if children with this probiotic supplement have better stool characteristics and a more beneficial composition of the fecal and skin flora than children given a placebo during the first 3 months of life.",[109,28,110],"Colic","Eczema Atopic Dermatitis",[112,113,114,115,116,117,118],"Preventive effect","Limosilactobacillus reuteri","L. reuteri","crying","colic","healthy infants","newborns","RECRUITING","2026-02-16",{"date":122,"type":35},"2026-02-19",{"date":124,"type":35},"2026-01-31",{"date":126,"type":22},"2028-12",{"name":128,"class":93},"Universitair Ziekenhuis Brussel",{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":16,"sex":17,"minAge":136,"maxAge":18,"enrollmentInfo":137,"targetDuration":4,"studyType":23,"phases":139,"briefSummary":140,"conditions":141,"keywords":142,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":94},"100543888","efficacy-of-two-hmos-in-chinese-infants-100543888","NCT06361719","Efficacy of Two HMOs in Chinese Infants","Efficacy of a Ready to Feed (RTF) Starter Liquid Infant Formula Containing 2'FL and LNnT in Chinese Infants: A Double-blind, Randomized Controlled Trial Including a Breastfed Reference Group","Inclusion Criteria:\n\n* Healthy male and female infants of post-natal age of 3-14 days (date of birth = day 0), inclusive, at enrolment\n* Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)\u002F legally accepted representatives LAR have been informed of all pertinent aspects of the trial.\n* Infants whose parent(s) have reached the legal age of majority in China.\n* Infants whose parent(s)\u002FLAR are willing and able to comply with scheduled visits, and the requirements of the trial protocol.\n* Infants whose parent(s)\u002FLAR can be contacted directly by telephone throughout the trial.\n* Infants whose parent(s)\u002FLAR have a working freezer.\n* Singleton, healthy, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.\n* For the formula-fed groups: infant is exclusively consuming and tolerating a cow' s milk infant formula for at least 3 days prior to enrolment. The infant's mother has independently elected not to breastfeed.\n* For the breastfed reference group: infant has been exclusively consuming breastmilk since birth (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established) and the infant's mother has made the decision to continue exclusively breastfeeding until at least 3 months of age.\n\nExclusion Criteria:\n\n* Infants with conditions requiring infant feedings other than those specified in the protocol.\n* Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrolment.\n* Infants who have a medical condition or history that could increase the risk associated with trial participation or interfere with the interpretation of trial results, including: Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). Documented or suspected systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis). Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the trial.\n* Infants who are presently receiving or have received prior to enrolment probiotic supplements or any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and\u002For metabolism (e.g., pancreatic enzymes); stool characteristics and microbiota (e.g., oral and systemic antibiotics, glycerine suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.\n* Currently participating or having participated in another clinical trial since birth.\n* Infant who has known or suspected cows' milk protein intolerance \u002F allergy, lactose intolerance, soy intolerance \u002F allergy.","3 Days",{"count":138,"type":22},262,[25],"This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group.",[28],[143,144,145,146,147,148],"Human Milk Oligosaccharides","Infant gut microbiota","Infant gut health","Immune response","Growth","Tolerance","2025-11-26",{"date":151,"type":35},"2025-11-28",{"date":153,"type":35},"2024-07-29",{"date":155,"type":22},"2027-06",{"name":40,"class":41},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":16,"sex":17,"minAge":164,"maxAge":136,"enrollmentInfo":165,"targetDuration":4,"studyType":23,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":4},"100611586","efficacy-of-a-new-infant-formula-composition-on-gut-health-in-infants-100611586","NCT07242508","Efficacy of a New Infant Formula Composition on Gut Health in Infants","Efficacy of a New Infant Formula Composition on Gut Health in Infants: A Prospective Randomized Double-blind Placebo-controlled Trial","Inclusion Criteria:\n\n* Healthy, full term, infants with a birth weight between 2500-4500 grams\n* Parents independently from study decided to not breastfeed their infant\n* Parents agree to feed the assigned study formula as the infant's sole source of nutrition for the duration of the study\n* have read and voluntarily signed an informed consent form\n* parents are capable of completing study procedures required by the protocol\n\nExclusion Criteria:\n\n* suffering from any anatomic and\u002For physiologic condition that would interfere with normal growth, development or feeding\n* are required to take medications or supplements known to influence growth and development\n* have a maternal history with known adverse effects on the fetus and\u002For the newborn infant\n* have previous or current antibiotics use (antibiotics administered during delivery are permitted)\n* have received or are planning to receive probiotics, prebiotics, or nutritional supplements prior to and throughout the trial (excluding vitamin D and vitamin K supplementation)\n* personal history of or parents\u002Fsiblings diagnosed with cow's milk protein allergy or lactose intolerance\n* multiple birth\n* participation in another trial","0 Days",{"count":166,"type":22},120,[25],"The aim of this study is to investigate potential health benefits of the experimental formula. The main objective is whether the experimental formula elevates the relative abundance of Bifidobacterium in stool samples after 10 weeks, as compared a standard formula, aka control formula. In addition other markers of gut health, such as stool characteristics, and gut health symptoms will be monitored",[28],[171,172,173,174,175],"infant","formula","microbiota","gut health","RCT","2025-11-17",{"date":178,"type":35},"2025-11-21",{"date":180,"type":22},"2025-11-25",{"date":182,"type":22},"2026-08-19",{"name":184,"class":41},"FrieslandCampina",{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":191,"eligibilityCriteria":192,"healthyVolunteers":16,"sex":17,"minAge":164,"maxAge":103,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":195,"briefSummary":196,"conditions":197,"keywords":198,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":211},"100597109","probiotic-for-infants-100597109","NCT07054216","Probiotic for Infants","Efficacy of a Probiotic on Gut Health, Immune Maturation, and Well-being in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Study","BABIES II","\"Inclusion Criteria\"\n\nInclusion Criteria for the pregnant person\n\n1. Pregnant person above 18 years of age in gestational week 36+0-38+0 (at Visit 0)\n2. Singleton pregnancy\n3. Ability to read and speak Danish\n4. Plan to breastfeed\n5. Provided voluntary written informed consent.\n\nInclusions Criteria for the newborn\n\n1. Born at full-term ≥37+0\n2. Birth weight ≥ 2500 g\n3. APGAR score of ≥ 7 within the first 5 min of life.\n\n\"Exclusion Criteria\" Exclusion Criteria for the pregnant person\n\n1. Pregnancy at 38 weeks + 0 or later at the time of recruitment\n2. Pregnancy with significant fetal abnormality at ultrasound scan of the fetus at gestational age 19-20 weeks\n3. Alcohol or drug abuse\n4. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre\n5. Pregnant person with any contraindications for breastfeeding.\n\nExclusion Criteria for the newborn\n\n1. Congenital disorders that could affect their safety or the study outcome\n2. Admission to Neonatal Intensive Care Unit for more than 24 hours\n3. Participation in another clinical intervention study which can interfere with this probiotic intervention\n4. Probiotics other than the study product.",{"count":194,"type":22},378,[25],"The BABIES II study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with an 8½ months intervention period from 14 days of age to 9 months of age followed by a 3-months short-term follow-up period until 1 year of age and a possible long-term follow-up until 18 years of age. The study will evaluate the effect of supplementation with a probiotic strain on different health outcomes.",[28],[199,200,201],"Infant","Gastrointestinal Microbiome","Diet, Food, and Nutrition","2025-08-27",{"date":204,"type":35},"2025-08-28",{"date":206,"type":35},"2025-08-25",{"date":208,"type":22},"2028-07-01",{"name":210,"class":93},"Hvidovre University Hospital",2,{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":16,"sex":17,"minAge":220,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":94},"100591183","maternal-high-fibre-fermented-diet-effect-on-breastfed-infant-gut-microbiome-100591183","NCT06977113","Maternal High Fibre Fermented Diet Effect on Breastfed Infant Gut Microbiome","The Effect of Maternal High Fibre and Fermented Food Rich Diet on Breastfed Infant Gut Microbiome: A Randomised Controlled Trial","MumBabyGut","Inclusion Criteria:\n\n* Healthy breastfeeding women aged 18 years old and older.\n* Healthy singleton full-term infants (girls and boys) aged between 2 and 5 months old and who are exclusively breastfed.\n* Not using lifelong medications and antibiotics in the past 12 weeks prior to the study.\n* Not using prebiotic or probiotic supplements in the past 4 weeks prior to the study.\n* No serious problems preventing participants from breastfeeding their babies.\n* No food allergies or intolerances.\n* No chronic conditions like diabetes, cancer, heart disease, bowel disorders, eating disorders, or any illness requiring regular medical care or lifelong medication.\n* No history of complications during pregnancy (e.g., preeclampsia and gestational diabetes).\n\nExclusion Criteria:\n\n* Expecting two or more children (i.e., multiple births; twins, triplets).\n* Not exclusively breastfeeding their infants (i.e., introduced formula or solids) or having medical conditions known to contraindicate breastfeeding (e.g., classic galactosemia, human immunodeficiency virus (HIV-virus) infection, untreated tuberculosis (TB)).\n* Preterm birth.\n* Clinically diagnosed with chronic medical conditions (e.g., type 1 and type 2 diabetes mellitus, cancer, cardiovascular diseases, and mental illnesses).\n* Medical conditions affecting gastric digestion or absorption (e.g., inflammatory bowel diseases (IBD), and irritable bowel syndrome (IBS)).\n* Conditions interfering with intervention intake (e.g., celiac disease, gluten hypersensitivity or lactose intolerance).\n* History of gestational complications.\n* Use of antibiotics in the past 12 weeks prior to the study.\n* Use of prebiotic or probiotic supplements in the past 4 weeks prior to the study.\n* Following exclusionary or restrictive diets (e.g., gluten-free, or weight loss).","2 Months","45 Years",{"count":223,"type":22},56,[25],"Breastfeeding is recommended for babies from birth to six months old because breast milk provides all the nutrients babies need for growth and development. Breast milk contains sugars called oligosaccharides, which support the development of a healthy gut in babies. The foods that breastfeeding mothers eat might influence the sugars in their breast milk and the natural, friendly bacteria inside their babies' gut-called the gut microbiota-which are important for overall health. Fibre-rich foods like fruits, vegetables, whole grains, beans, and nuts, as well as fermented foods like yogurt and milk kefir, support a healthy gut.\n\nThe main aim of this study is to find out whether eating foods rich in fibre and fermented foods by breastfeeding mothers can affect the bacteria residing in the gut of their breastfed babies. The study will also explore how this diet affects the mother's gut microbiota, breast milk composition, and gastrointestinal (GI) symptoms for both mothers and babies.\n\nThe main question of the study is: Does a 2-week diet high in fibre and fermented foods consumed by breastfeeding mothers affect the gut microbiota of their breastfed babies aged 2 to 5 months, compared to mothers following their habitual diet?\n\nParticipants will:\n\n* Be randomly assigned to one of two groups: (1) one group will follow a specific diet high in fibre and fermented foods (25 g of fibre\u002Fday + 3 servings of fermented foods\u002Fday) in addition to their habitual diet, or (2) the second group will continue with their habitual diet (no specific foods will be provided) (16 g of fibre\u002Fday).\n* Attend a single study visit at the study location.\n* Provide body measurements (weight and height) of mothers and babies at the. study visit, and provide weight only during each home visit.\n* Complete gut health questionnaires for both mothers and babies twice during the study.\n* Complete two sets of 3-day, 24-hour dietary recalls during the study.\n* Provide stool samples (3 from babies and 2 from mothers) and 2 breast milk samples.\n\nResearchers will then compare the stool samples from both mothers and babies to see whether the specific diet makes any difference to the gut microbiota.",[227,28],"Healthy Mothers",[229,230,231,232,233,234,235,236,237],"maternal diet","breast milk","infant gut microbiome","dietary fibre","fermented food","human milk oligosccharide","short chain fatty acids","gut microbiota","Exclusive breastfeeding","2025-06-17",{"date":240,"type":35},"2025-06-24",{"date":242,"type":35},"2025-03-11",{"date":244,"type":22},"2028-05",{"name":246,"class":93},"University of Glasgow",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":103,"enrollmentInfo":255,"targetDuration":4,"studyType":23,"phases":257,"briefSummary":258,"conditions":259,"keywords":260,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":94},"100576760","characterization-of-the-gastrointestinal-microbiota-in-newborn-infants-100576760","NCT06789484","Characterization of the Gastrointestinal Microbiota in Newborn Infants","Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study","BABIES I","Inclusion Criteria:\n\n* Inclusion Criteria for the pregnant person:\n\n  1. Healthy pregnant person in gestational week 36+0-38+0\n  2. Age ≥ 18 years\n  3. Normal singleton pregnancy\n  4. Ability to read and speak Danish\n  5. Normal ultrasound scan of the fetus at gestational age 19-20 weeks\n  6. Plan to exclusively breastfeed\n  7. Provided voluntary written informed consent.\n* Inclusions Criteria for the newborn:\n\n  1. Born at full-term ≥37+0\n  2. Birth weight above 2500 g\n  3. APGAR score of at least 7 within the first 5 min of life.\n\n     Exclusion Criteria:\n* Exclusion Criteria for the pregnant person:\n\n  1. Pregnancy at over 38+0 weeks' gestation at recruitment\n  2. Multiple pregnancy\n  3. Pregnancy with any fetal abnormality\n  4. Alcohol or drug abuse\n  5. Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre\n  6. Any contraindications for breastfeeding.\n\nExclusion Criteria for the newborn :\n\n1. Congenital disorders that could affect their safety or the study outcome\n2. Admission to Neonatal Intensive Care Unit for more than 24 hours\n3. Participation in another clinical intervention study which can interfere with this probiotic intervention\n4. No other probiotics than the study product.",{"count":256,"type":22},40,[25],"The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain.\n\nThe aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).",[28],[199,200,201],"2025-04-10",{"date":263,"type":35},"2025-04-13",{"date":265,"type":35},"2025-03-04",{"date":267,"type":22},"2025-12-31",{"name":210,"class":93},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":16,"sex":17,"minAge":164,"maxAge":19,"enrollmentInfo":277,"targetDuration":4,"studyType":23,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":211},"100564650","hmos-on-infant-gut-microbiota-modulation-and-development-of-the-immune-system-in-healthy-infants-100564650","NCT06631937","HMOs on Infant Gut Microbiota Modulation and Development of the Immune System in Healthy Infants","The Effect of Human Milk Oligosaccharides on Infant Gut Microbiota Modulation, Development of the Immune System and Health Later in Life: the BELIEF Study","BELIEF","Inclusion Criteria:\n\n• All infants which parents has decided mode of feeding\n\nExclusion Criteria:\n\n* Premature birth",{"count":278,"type":22},334,[25],"The goal of this clinical trial is to learn how a mixture of human milk oligosaccharides impacts the development of the infant microbiota, the immune maturation and how the interaction between the microbiota and immune maturation may impact both short and long term health of the infant.\n\nThe participants will:\n\n* Consume the investigational products (active\u002Fplacebo) for 6 months\n* Legal guardians\u002Fparents to the participant to collect stool samples from the diapers at home\n* Legal guardians\u002Fparents to the participant to report gastrointestinal symptoms, signs of infections in an electronic questionnaire\n* Visit the clinic for checkups and dried blood sample collection\n\nFor reference, a group of breastfed infants will be included. They will undergo the same procedures apart from consuming the investigational product (active\u002Fplacebo). 230 participants (115 in each intervention arm) will be randomized to an intervention and 104 participants will be recruited for the reference group, giving a total sample size of 334 participants.\n\nThe intervention trial will be reported in two steps, first step covering the intervention phase from birth to 6 months; and step two includes both the intervention phase (0-6 months) and the follow-up period from 6-12 months. Informed consents for the possibility to preform long-term follow-up will be obtained.",[28],[283,284,285,286,287],"infants","gastrointestinal microbiome","immune development","gastrointestinal well-being","infant formula fed","2024-11-07",{"date":290,"type":35},"2024-11-12",{"date":292,"type":35},"2024-11-05",{"date":294,"type":22},"2027-08",{"name":296,"class":93},"University of Aarhus"]