[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nutricia Research\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":224},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,76,108,129,152,172,201],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100617862","effect-of-young-child-formula-on-iron-status-in-children-1-3-years-of-age-100617862",false,"NCT07324135","Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.","A Double-blind Randomized Controlled Study to Evaluate the Effect of Young Child Formula on Iron Status in Children 1-3 Years of Age.","Inclusion Criteria:\n\n* Children aged 1 to 3 years\n* Healthy children (as per investigator clinical judgement and non-anaemic as confirmed by Hb levels) or meeting the criteria for mild anaemia based on Hb levels\n* Children familiar with drinking milk products (in combination with breastfeeding or not) for at least 3 weeks prior to screening.\n* Written informed consent provided by parent(s) \u002F legally acceptable representative(s) aged ≥18 years at screening\n\nExclusion Criteria:\n\n* Low Hb meeting the criteria for moderate or severe anaemia\n* Use of iron and\u002For fibre supplementation within 3 months prior to screening\n* Any infection within 2 weeks prior to screening\n* Any other medical condition with known high CRP (\\>5 mg\u002FL) \u002F high AGP (\\>1 g\u002FL) value within 2 weeks prior to screening\n* The use of medication that is likely to interfere with iron metabolism) within 2 weeks prior to screening\n* The use of medication to treat iron deficiency or anaemia within 3 months prior to screening\n* Any developmental delays that could impact feeding behaviour or growth, or any other condition that is likely to influence nutritional status or growth.\n* Disorders requiring a special diet.\n* Any other iron metabolism and related disorders\n* Children with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances.",true,"ALL","12 Months","36 Months",{"count":21,"type":22},466,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study evaluates the effect of young child formula in children 1-3 years of age. Subjects will receive either test or control product. Growth and health data, parent diaries and biological samples will be collected during the study.",[28],"Iron Status",[30,31,32,33],"YCF","Young Child Formula","Anaemia","Iron status","NOT_YET_RECRUITING","2025-12-23",{"date":37,"type":38},"2026-01-07","ACTUAL",{"date":40,"type":22},"2026-01",{"date":42,"type":22},"2027-01",{"name":44,"class":45},"Nutricia Research","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":16,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":46},"100611680","amino-acids-in-the-blood-after-eating-yoghurt-and-milk-proteins-100611680","NCT07243730","Amino Acids in the Blood After Eating Yoghurt and Milk Proteins","Determination of the Early Postprandial Essential Amino Acid Bioavailability of Yogurt vs Milk A Randomized Controlled Clinical Trial in Healthy Volunteers - A Bioavailability Study -","NutraFerm2","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 40 years at the time of (Informed Consent Form) ICF signature\n2. Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg\u002Fm2\n3. Signed informed consent\n4. Willingness and ability to comply with the protocol\n5. Judged by the Investigator to be in good health.\n\nExclusion Criteria:\n\n1. Any known surgery or ongoing medical condition that interferes significantly with protein absorption and digestion, and\u002For gastrointestinal (GI) function in the opinion of the investigator, including but not limited to the following: phenylketonuria, pancreatitis, short bowel syndrome, inflammatory bowel disease, celiac disease, gastroesophageal reflux disease, gastric ulcer, chronic gastritis, gastrointestinal cancer, esophageal and\u002For gastric surgery, and any cardiovascular disease (such as hypertension, arrhythmia, or atrial fibrillation) which is not controlled with the use of medication\u002Ftherapy.\n2. Known renal or hepatic diseases that may interfere with protein metabolism in the opinion of the investigator, including but not limited to acute hepatitis, chronic liver disease, nephritis, cystinuria, chronic kidney disease.\n3. Use of systemic medication within the past 3 weeks prior to screening which in the opinion of the investigator may influence gastric acid production and\u002For gastrointestinal motility or function and\u002For protein metabolism (e.g., antibiotics, anticonvulsants, prokinetics, antacids or gastric acid inhibitors, opioid analgesics, anticoagulants, corticosteroids, laxatives, growth hormone, testosterone, immunosuppressants, or insulin).\n4. Known Diabetes Mellitus Type I or Type II, insulin resistance, or metabolic syndrome.\n5. Any ongoing cancer and\u002For cancer treatment (except for non-melanoma skin cancer or carcinoma in situ).\n6. Known anaemia.\n7. A blood donation within 56 days (8 weeks) for men; or 122 days (4 months) for women; prior to the screening.\n8. Any known bleeding disorder.\n9. Adherence to a strict dietary regime (e.g. vegetarian\u002F vegan\u002F paleo\u002F ketogenic\u002F intermittent fasting\u002F high protein diet (\\>1.6 g\u002Fkg body weight\u002Fday)) or a weight loss program.\n10. Any known allergies or intolerances to ingredients of the study product, i.e. cow's milk allergies, lactose intolerance.\n11. Known pregnancy and\u002For lactation.\n12. Current smoking \u002F vaping \u002F use of e-cigarette \u002F or stopped smoking for \\\u003C 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes\u002F e-cigarettes\u002F cigars\u002F pipes per week on average in the last month prior to screening).\n13. Average alcohol use of \\> 21 glasses per week for men or \\> 14 glasses per week for women (on average during the last 6 months prior to screening).\n14. Drug or medicine abuse in the opinion of the investigator.\n15. Current eating disorders, e.g. anorexia nervosa, bulimia nervosa, binge eating disorder.\n16. Use of protein, amino acid, or creatine supplements within 4 weeks prior to screening.\n17. Known difficulties with placement of and\u002For blood drawings from a cannula.\n18. Participation in any other clinical study with investigational or marketed products concomitantly or within four weeks before study visit 1.\n19. Major medical or surgical event requiring hospitalization within the preceding 3 months and\u002For scheduled in the period of study participation relevant in the opinion of the investigator.\n20. Investigator's uncertainty about the willingness or ability of the participant to comply with the protocol requirements.\n21. Employees of Danone Global Research \\& Innovation Center and of the investigational site and\u002For their family members or relatives.","18 Years","40 Years",{"count":58,"type":22},30,[25],"Participants will visit the study site twice in a fasting state. Participants asked to consume one of the two study products in a random order. Participants will consume one serving of the study product (T = 0 minutes). Study product intake should take place within 10 minutes (+\u002F-5 minutes). Two blood samples will be taken at baseline and then at 14 timepoints after product intake. A follow up call will take place 7 (-3\u002F+7) days after the final study visit.",[62],"Bioavailability of Amino Acids",[64,65,66],"Amino acids","Yogurt","Milk","RECRUITING","2025-12-16",{"date":70,"type":38},"2025-12-17",{"date":72,"type":38},"2025-11-07",{"date":74,"type":22},"2026-09",{"name":44,"class":45},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":16,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100608865","effect-of-follow-on-formula-on-the-gut-microbiota-of-healthy-infants-100608865","NCT07207109","Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.","A Double-blind Randomised Controlled Study to Investigate the Effect of a follow-on Formula With a Specific Synbiotic Mixture on the Gut Microbiota Composition in Healthy Infants.","FUNTASTIC","Inclusion Criteria:\n\n1. Healthy infants as per the clinical judgement of the Investigator\n2. Singleton infants\n3. Infants ≥6 months and ≤9 months of age at Visit 1\n4. Infant's weight-for-age WHO z-score within ± 2 SD at Visit 1\n5. Infants fed with an infant or follow-on formula at Visit 1.\n6. Infants are familiar with, and are expected to drink, ≥600 mL formula per day.\n7. Written informed consent (IC) from parent(s) and\u002For legally acceptable representative(s) aged ≥18 years at Visit 1.\n\nExclusion Criteria:\n\n1. Infants with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances\n2. Infants who received breastfeeding ≤14 days before Visit 1\n3. Infants who are potty-trained\n4. Infants with current or previous illnesses\u002Fconditions and\u002For known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.\n5. Use of medication or nutritional products\u002Ffood supplements known to impact the study outcomes ≤14 days before Visit 1 or expected need during the study.\n6. Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.\n7. Incapability of infants' parents and\u002For legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements, including access to a phone.\n8. Children of employees and\u002For family members or relatives of employees of Danone, the participating sites, or any other nutrition company that develops infant, follow-on or young child formulae.","6 Months","9 Months",{"count":87,"type":22},268,[25],"This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will be recorded. Infants will be randomly assigned to receive either the test or control product. Growth and health data will be collected during study visits.\n\nParents will collect stool samples and complete diaries to help researchers better understand the baby's digestion and overall health. A follow-up phone call will be made to check on the baby's well-being after the study ends.",[91,92,93,94],"Follow-on Formula","Infant","Faeces","Gut Microbiota",[96,97,98],"Follow-on formula","healthy infants","gut microbiota","2025-10-02",{"date":101,"type":38},"2025-10-03",{"date":103,"type":22},"2025-11",{"date":105,"type":22},"2027-06",{"name":44,"class":45},2,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":23,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":107},"100576155","effect-of-plant-based-high-energy-high-protein-oral-nutritional-supplement-on-nutritional-intake-in-patients-with-or-at-risk-of-disease-related-malnutrition-100576155","NCT06781619","Effect of Plant Based High Energy High Protein Oral Nutritional Supplement on Nutritional Intake in Patients With or at Risk of Disease Related Malnutrition.","PRO-PLANT","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Identified as at medium or high risk of malnutrition based on:\n\n   1. MUST score ≥ 1 and \u002F or\n   2. Being prescribed with ONS and willing and able to switch from pre-study prescribed ONS to the Test or Control Product for participation in the study\n3. In need of 2 servings of ONS\u002Fday (400 kcal; 20 gr protein per serving) for at least 8 weeks as determined by the treating healthcare professional.\n4. Medically and physically able to consume high energy high protein ONS in the opinion of the Investigator.\n5. Willing to maintain dietary habits for the duration of the study.\n6. Willing to consume plant based as well as dairy based ONS\n\nExclusion Criteria:\n\n1. Known allergy to soy, cow's milk protein or to any other ingredients as listed in the study product composition (refer to the product information brochure (PIB) and the appendix of this protocol).\n2. Known intolerance to any ingredients as listed in the study product composition (refer to PIB and appendix of this protocol). Subjects with lactose intolerance who use lactase may still be enrolled in the study.\n3. Any contraindication to oral feeding per se, including gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intraabdominal sepsis.\n4. Active flare of inflammatory bowel disease as defined by Harvey-Bradshaw Index (HBI) \\>6 (Crohn's disease) or Simple Clinical Colitis Activity Index (SCCAI) \\>5 (ulcerative colitis).\n5. Requiring a protein restricted diet as confirmed by a physician, for example chronic kidney disease stage 4 and 5 (estimated by Glomerular Filtration Rate \\\u003C30 mL\u002Fmin\u002F1.73 m2).\n6. Requiring enteral nutrition (via tube delivery) or parenteral nutrition.\n7. Subjects following a vegan diet.",{"count":116,"type":22},80,[25],"The subjects will use study product twice daily for 8 weeks starting at Visit 1. The recommendation is to consume one serving in the morning and one in the afternoon \u002F evening between meals. The duration of the study for each subject will be approximately 11 weeks, comprising a screening period of max 2 weeks, an intervention period of 8 weeks, and a follow up phone call 1 week after completion of the intervention. A blood sample will be drawn at visit 1 and visit 3.",[120],"Disease Related Malnutrition","2025-09-23",{"date":123,"type":38},"2025-09-24",{"date":125,"type":38},"2025-03-17",{"date":127,"type":22},"2027-07",{"name":44,"class":45},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":23,"phases":140,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100565668","effect-of-an-oral-nutritional-supplement-ons-with-prebiotic-fibre-compared-to-a-non-fibre-containing-ons-equal-in-energy-and-protein-content-on-gut-microbiota-in-older-adults-with-or-at-risk-of-disease-related-malnutrition-100565668","NCT06645171","Effect of an Oral Nutritional Supplement (ONS) with Prebiotic Fibre Compared to a Non-fibre Containing ONS Equal in Energy and Protein Content on Gut Microbiota in Older Adults with or At Risk of Disease Related Malnutrition","Effect of an Oral Nutritional Supplement (ONS) with Prebiotic Fibre Compared to a Non-fibre Containing ONS Equal in Energy and Protein Content on Gut Microbiota Bifidobacteria in Older Adults with or At Risk of Disease Related Malnutrition","BISON","Inclusion Criteria:\n\n* 1\\. 65 years of age or older 2. Identified as at medium or high risk of malnutrition based on:\n\n  a) MNA-SF score between 0 - 11 and \u002F or b) are prescribed with ONS 3. In need of 2 servings of oral nutritional support\u002Fday (300 kcal; 12 gr protein per serving).\n\n  4\\. a) Not being prescribed with ONS or b) being prescribed with non-fibre containing ONS and willing and able to switch from pre-study prescribed ONS to the Test or Control Product for participation in the study.\n\n  5\\. Willing to maintain dietary habits for the duration of the study. Written informed consent from subject (or impartial witness after verbal consent of subject when subject is physically unable to sign and where allowed by local regulations).\n\nExclusion Criteria:\n\n* 1\\. Requirement for a fibre-free diet. 2. Have used nutritional supplements with fibre\u002Fprebiotics and\u002For probiotics content at any point during 3 weeks prior to start study (Visit 1) and \u002F or will not refrain from using these kinds of products during the study period.\n\n  3\\. Admitted to an intensive care unit. 4. Hemodynamically unstable. 5. Known allergy to cow's milk protein. 6. Known galactosaemia. 7. Known hepatic encephalopathy. 8. Known Irritable Bowel Syndrome. 9. Known severe lactose intolerance without using lactase. 10. Known history of GI surgery. 11. Known history of intestinal polyp removal within 3 months prior to the study.\n\n  12\\. Known history of Immunotherapy. 13. Known history of GI cancer. 14. Active cancer treatment or within 12 months prior the study 15. Diagnose of Celiac Disease. 16. Received antibiotics within 4 weeks prior to study. 17. Patients following a vegan or vegetarian diet. 18. Active flare of inflammatory bowel disease as defined by HBI \\>6 (Crohn's disease) or SCCAI \\>5 (ulcerative colitis).\n\n  19\\. Stricturing Crohn's disease. 20. Any contraindication to oral feeding per se being: gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis.\n\n  21\\. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or Alzheimer's disease.\n\n  22\\. Planned hospital admission during the study period in case not hospitalised at screening 23. Participation in any other studies involving investigational or marketed products concomitantly or within 6 weeks prior to baseline.\n\n  24\\. Severe disease with life expectancy less than a year.","65 Years",{"count":139,"type":22},62,[25],"This study assesses the effects of an oral nutritional supplement (ONS) with fibre compared to a non-fibre containing ONS equal in energy and protein content on gut microbiota bifidobacteria in older adults with or at risk of disease related malnutrition. It is a randomised controlled, double blind, parallel-group, multi-country study. Subjects will receive an ONS with or without (control group) fibre. They take it twice a day for 4 weeks and the change in their gut microbiota bifidobacterial levels is the primary outcome. They will be measured at day 1 (V1), day 15 (V2) and week 4 (V3).",[143],"Changes in Gut Microbiota Bifidobacterial Levels","2024-10-15",{"date":146,"type":38},"2024-10-16",{"date":148,"type":22},"2024-11",{"date":150,"type":22},"2026-12",{"name":44,"class":45},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":16,"sex":17,"minAge":137,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":23,"phases":162,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":4},"100565669","adding-appetite-stimulants-to-an-ons-in-older-adults-100565669","NCT06645184","Adding Appetite Stimulants to an ONS in Older Adults","Effects of Adding Appetite Stimulants to a Fibre Containing High-Protein ONS on Appetite-Related Outcomes in Older Adults","APPOLO II","Inclusion Criteria:\n\n1. 65 years of age or older\n2. Able to consume high energy and\u002For high protein ONS at discretion of the Investigator\n3. Written informed consent\n4. Willing and able to refrain from smoking during the visits\n5. Able to speak and read in Dutch to communicate with the site staff and comply with the instructions and requirements of the study.\n\nExclusion Criteria:\n\n1. Any known condition that interferes with the gastric emptying (e.g., gastroparesis, gastric stoma, hypothyroidism, hyperthyroidism, multiple sclerosis, Parkinson disease).\n2. Any known metabolic condition that interferes with the breakdown of amino acids (e.g. arginase deficiency, urea cycle disorder)\n3. Known history of gastric surgery e.g. (partial) gastrectomy or any other procedure for stomach volume reduction, including gastric banding, gastric balloon.\n4. Any known chronic\u002Fcontinuous use, and\u002For within 24-48h before the visit, of medication that strongly affects with gastric emptying or gastric acid secretion (e.g., metoclopramide, opioid analgesics, calcium channel blockers, Beta-Adrenergic Receptor Agonists, H2 receptor antagonists, proton pump inhibitors; tricyclic antidepressants such as amitriptyline, imipramine, systemic steroids)\n5. Known active cancer treatment 4 weeks prior the study start\n6. Body Mass Index \\>= 30.0 kg\u002Fm²\n7. Presence of Diabetes Mellitus (self-reported or the use of Diabetes medication: i.e., insulin, biguanides, DPP-4 inhibitors, GLP-1 receptor agonists)\n8. Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements, for example due to the presence of a psychiatric disorder (e.g. major depression, psychoses), dementia or Alzheimer's disease\n9. Known renal dysfunction with protein restriction diet\n10. Known allergy to cow's milk protein\n11. Known allergy to soy\n12. Known galactosaemia\n13. Known lactose intolerance\n14. Excessive alcohol consumption (use of \\> 14 units per week for women or \\> 21 units per week for men, on average during the past 6 months).\n15. Drug abuse based on investigator's judgement.\n16. Any contraindication to oral feeding per se being: any degree of dysphagia, gastrointestinal failure or suppressed gastrointestinal function, complete intestinal obstruction and major intra-abdominal sepsis.\n17. Enrolment in any other studies involving investigational or marketed products concomitantly or within two weeks prior to baseline\n18. Employees, family members or other relatives of employees of the participating centre or of Danone Global Research \\& Innovation Center.",{"count":161,"type":22},48,[25],"Study to determine whether adding specific nutrients to a high-protein oral nutritional support (ONS), with and without fibre can reduce the feeling of satiety and may increase appetite in adults older than 65 years. This contributes to research into a new type of nutritional nutrition for people with disease related malnutrition (DRM)",[165],"Malnutrition",{"date":146,"type":38},{"date":168,"type":22},"2024-10",{"date":170,"type":22},"2025-06",{"name":44,"class":45},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":16,"sex":179,"minAge":55,"maxAge":4,"enrollmentInfo":180,"targetDuration":4,"studyType":182,"phases":4,"briefSummary":183,"conditions":184,"keywords":187,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":46},"100514517","a-study-in-lactating-mothers-and-their-newborns-to-analyse-the-composition-of-human-milk-100514517","NCT05979532","A Study in Lactating Mothers and Their Newborns to Analyse the Composition of Human Milk","A Longitudinal Prospective, Observational, Cohort Study in Lactating Mothers and Their Newborns to Further Unravel the Complexity of Human Milk","Inclusion Criteria:\n\n* Pregnant women in the third trimester of pregnancy (≥28 weeks) who have the intention to provide breastfeeding for at least 6 months post-partum.\n* Age ≥ 18 years.\n* Willingness to provide residual human milk.\n* Living in proximity of NCRU (clinical site in NL).\n* Dutch speaking and reading.\n* Freezer -18°C available.\n* Having mobile phone, tablet, or computer available.\n* Signed informed consent from the subject (pregnant woman).\n* Signed informed consent from the other parent and\u002For legally acceptable representative, of the unborn baby(s), aged ≥ 18 years.\n\nExclusion Criteria:\n\n* Pregnant women known positive for human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV).\n* Multiple pregnancy \\> 2.\n* Incapability of subjects to comply with study protocol as per the judgment of the site staff (e.g. fluency in local language, access to laptop\u002Fsmartphone devices and internet connection required for data collection).\n* Women (and their unborn baby(s)) with current or intended participation in any other clinical study involving investigational or marketed products.\n* Employees and\u002For children\u002Ffamily members or relatives of employees of Nutricia Research or the participating site.\n\nContinuation exclusion criteria (after birth)\n\n* Stillbirth\n* Newborn having any congenital abnormality, chromosomal disorder or severe disease that would prevent the infant from breastfeeding and\u002For growing normally based on the opinion of a health care professional and\u002For study physician.\n* No donation of any milk sample within the first 8 weeks postpartum (timepoints week 1, week 1.5, and week 4).","FEMALE",{"count":181,"type":22},172,"OBSERVATIONAL","The current longitudinal (max. 2-year) observational cohort study in 120 lactating mothers and their newborns will make it possible to explore human milk composition across different lactation stages, between different human milk groups, and in relation to maternal, perinatal, infant, and sample characteristics as well as to the microbiota of the infant.",[185,186],"Breast Feeding","Milk, Human",[185,188,189,190,191,192],"Human milk","Research","Lactation","Human Milk Oligosaccharide","HMO","2024-03-14",{"date":195,"type":38},"2024-03-15",{"date":197,"type":38},"2024-02-13",{"date":199,"type":22},"2027-08-31",{"name":44,"class":45},{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":16,"sex":17,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":182,"phases":4,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":46},"100473812","a-follow-up-study-with-children-who-participated-in-the-tempo-study-in-their-first-year-of-life-100473812","NCT05449756","A Follow-up Study With Children Who Participated in the TEMPO Study in Their First Year of Life","A Virtual, Decentralised Observational Follow-up Study Investigating Feeding Patterns in Infancy and the Associated Parent-reported Allergic Manifestations, Allergies and Infections in Childhood.","Inclusion Criteria:\n\n* Subjects are eligible to participate in the TEMPO Follow-Up study in case:\n* they completed the final (12 months) visit in the TEMPO study.\n* parents agree that their contact details will be shared with a third party for study purposes.\n* parents agree that data collected in the TEMPO study will be used in the TEMPO Follow-Up study.\n* parents provide written informed consent for participation in the TEMPO Follow-Up in accordance with local law.\n\nExclusion Criteria:\n\n* Parents who do not have a smartphone, tablet or personal computer with internet access.","3 Years","10 Years",{"count":211,"type":22},705,"This is a follow-up study of a randomised clinical trial, called TEMPO (a double-blind randomized clinical trial investigating infant formula and human breast milk consumption), in which infants participated in their first year of life. The investigators like to know if these children develop allergies or infections in childhood and whether their feeding pattern in infancy plays a role.",[214,215],"Allergy","Infections","2023-12-04",{"date":218,"type":38},"2023-12-11",{"date":220,"type":38},"2023-05-30",{"date":222,"type":22},"2029-03-31",{"name":44,"class":45},""]