[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Société des Produits Nestlé (SPN)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":429},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,39,65,93,116,138,161,183,207,229,252,278,304,328,358,384,410],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":13,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100542780","evaluation-of-the-effects-of-a-nutritional-intervention-of-ketogenic-medium-chain-triglycerides-and-b-vitamins-on-cognitive-functioning-in-older-adults-with-mild-cognitive-impairment-cogniket-mci-100542780",false,"NCT06347315","Evaluation of the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment (COGNIKET-MCI)","COGNIKET-MCI Trial: A Prospective, Randomized, Double-blind, Placebo-controlled, Multi-center, Multi-country, Pivotal Trial to Study the Effects of a Nutritional Intervention of Ketogenic Medium-chain Triglycerides (kMCT) and B-vitamins on Cognitive Functioning in Older Adults With Mild Cognitive Impairment","Inclusion Criteria:\n\n1. Have read, understood, and signed the informed consent form (ICF).\n2. Be aged ≥60 years at the time of screening.\n3. Presence of acquired memory complaints with a duration of \\>3 months. Here we refer to memory\u002Fcognitive complaints in a broader sense that can involve other cognitive domains other than memory. (As reported by the participant or reliable trial informant. Trial informants can be a relative, spouse or domestic partner, or close friend who interacts closely enough with the participant to be able to respond to assessments\u002Fquestionnaires as needed.)\n4. Have a clinical diagnosis of MCI (with a clinical phenotype compatible with AD, insidious SVD \\[ie, no post-stroke cognitive impairment\\], or mixed AD\u002FSVD) according to the participating site, or referring center, aligned with international\u002Fnational standards for MCI diagnosis, and additionally informed by a minimum of one of the following objective criteria as assessed by components of the Consortium to Establish a Registry for Alzheimer's Disease neuropsychological battery (CERAD NB):\n\n   1. Word list memory task: ≤19,\n   2. Word list recall: ≤5,\n   3. Fifteen-item subset of the Boston Naming Test (BNT): ≤13,\n   4. Constructional praxis recall: ≤7, or\n   5. Total CERAD score: ≤70.\n5. Full autonomy for daily living based on the Instrumental Activities of Daily Living (IADL)-Lawton scale:\n\n   1. Score for women: 8 or\n   2. Score for men: 5.\n6. Participants must have an available trial informant willing and able to attend the following 3 clinic visits with the participant: V1\u002Frandomization, V3\u002F12-month visit, and V4\u002F18-month visit.\n7. Participants must have a trial informant who in the opinion of the investigator, has contact with the trial participant for a sufficient number of hours per week (at least 2 hours per day and a minimum of 4 times per week).\n8. Participants and their trial informants have an adequate ability to read and write, as well as adequate vision and hearing for neuropsychological testing according to the investigator's judgment (corrective aids are allowed).\n9. CDR global score of 0 to 0.5 at screening.\n10. Sexually active females of childbearing potential (defined in further detail in Appendix 1 of the protocol) must practice 2 different highly effective methods of contraception with their heterosexual partner or remain abstinent during the trial and for 30 days after the last dose of nutritional formulation. If employing contraception, the highly effective methods of contraception detailed in Appendix 1 of the protocol must be followed.\n11. Females of childbearing potential must have a negative highly sensitive urine pregnancy test before randomization; a positive urine pregnancy test result must immediately be confirmed using a serum test.\n12. Participants able to satisfactorily comply with the protocol requirements.\n13. Participants willing and able to discontinue all prohibited concomitant medications to meet any protocol-required washout periods before and during the trial period (Section 9.6.1 of the protocol provides more details).\n\nExclusion Criteria:\n\n1. Diagnosis of a major neurocognitive disorder according to the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), or dementia according to the DSM-IV and the National Institute of Neurological and Communicative Diseases and Stroke\u002FAlzheimer's Disease and Related Disorders Association criteria at the time of enrollment.\n2. MCI related to past or recent concussion, COVID-19, or other specific etiologies (including neurodegenerative disease like Parkinson's disease, multiple sclerosis, Huntington's disease, Lewy-body disease, fronto temporal dementia), or associated with medication\u002Fsubstance use, per the investigator's judgment.\n3. A history of COVID-19 ≤120 days before screening or completion of a vaccination course against severe acute respiratory syndrome coronavirus 2 ≤14 days before screening. The vaccine received must have been authorized for emergency use or approved by the US Food and Drug Administration.\n4. Newly introduced, or change in dose, within the last 2 months before randomization, of physician-prescribed interventions or medications affecting cognition or AD (eg, acetylcholinesterase inhibitors, memantine, anti-amyloid-beta agents), or planned introduction of such medications during the trial.\n5. Participants who will likely require prohibited concomitant therapy during the trial based on the investigator's judgment.\n6. Known history of or ongoing alcohol or substance use disorder, based on medical history, that in the opinion of the investigator may conflict with the participant's participation.\n7. Participants who, in the opinion of the investigator, medical monitor, or sponsor should not participate in the trial.\n8. Symptoms suggestive of depression or anxiety according to the Hospital Anxiety and Depression Scale (HADS):\n\n   1. HADS-D ≥8 or\n   2. HADS-A ≥8.\n9. Known active HIV infection, COVID, hepatitis B, or hepatitis C based on medical history.\n10. Participants with epilepsy or a history of seizures, except for a single childhood febrile seizure, post-traumatic seizure, or alcohol withdrawal seizure.\n11. Participants considered to be in poor general health based on the investigator's judgment. Examples include participants who have recent clinically significant weight loss, chronic dehydration or hypovolemia, poor fluid or nutritional intake, or a recent clinically significant infection, as per the investigator's judgment.\n12. Cancer diagnosis in the past 2 years excluding select skin conditions considered to be fully treated (basal cell or squamous cell carcinomas of the skin) or early-stage cancer with excellent prognosis (eg, some prostate cancer conditions) according to the investigator's judgment.\n13. Renal disease (estimated glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F1.73m2) based on the investigator's assessment and historical data.\n14. Uncontrolled hypertension (systolic blood pressure \\>160 mm Hg, and\u002For diastolic blood pressure \\>100 mm Hg).\n15. Significant and uncontrolled thyroid disease according to the investigator's judgment.\n16. Any surgery or procedure requiring general anesthesia ≥3 hours, planned, or in the previous 3 months.\n17. Poorly regulated type 2 diabetes (HbA1c \\>9.0%), or type 2 diabetes that is currently treated with insulin, glucagon-like peptide-1 receptor analog (GLP-1 RA), or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, or type 1 diabetes.\n18. Vitamin B12 deficiency per the investigator's judgment, or current use of B-vitamin supplementation \\>200% daily recommended value according to national standards.\n19. Very high or severe hypertriglyceridemia (≥886 mg\u002FdL or 10.0 mmol\u002FL).\n20. Participants who are unable to comply with protocol procedures in the opinion of the investigator (if an individual develops a major neurocognitive disorder during the course of the trial, the appropriateness for the individual to continue will be based on the investigator's judgment).\n21. Have a personal or hierarchical link with the research team members.\n22. Participant who is a shift worker that involves night shifts.\n23. Ongoing\u002Fplanned pregnancy or breastfeeding at screening (female participants who have a positive pregnancy test result before receiving nutritional formulation will be excluded).\n24. Participants who follow a ketogenic diet or other diet that is intended to influence ketone levels (eg, prolonged fasting, intermittent fasting, ketogenic meal replacement product regimens), or take ketone-, kMCT-, or coconut oil supplementation, or adhere to a diet that excludes milk product use (eg, vegan diet).\n25. Cow's milk protein allergy or intolerance, or other allergy or intolerance to any of the ingredients of the nutritional formulation (eg, medium chain acyl-CoA deficiency, or other fatty acid oxidation disorders).\n\nUS protocol specificities:\n\n4\\. Have MCI (with a clinical phenotype compatible with AD, insidious SVD \\[ie, no post-stroke cognitive impairment\\], or mixed AD\u002FSVD) according to the participating site or referring center, as aligned with the National Institute on Aging and the Alzheimer's Association or Mayo Clinic standards for MCI, and additionally informed by a minimum of one of the following objective criteria as assessed by components of the Consortium to Establish a Registry for Alzheimer's Disease neuropsychological battery (CERADNB):\n\n1. Word list memory task: ≤19,\n2. Word list recall: ≤5,\n3. Fifteen-item subset of the Boston Naming Test (BNT): ≤13,\n4. Constructional praxis recall: ≤7, or\n5. Total CERAD score: ≤70.\n\n   6\\. Participants must have an available trial informant willing to attend the following 4 clinic visits with the participant: screening, V1\u002Frandomization, V3\u002F12-month visit, and V4\u002F18-month visit.\n\n   9\\. CDR global score of 0 at screening.\n\n   10\\. Sexually active females of childbearing potential must practice highly effective methods of contraception with their heterosexual partner (defined in further detail in Appendix 1 of the protocol) or remain abstinent during the trial and for 30 days after the last dose of nutritional formulation. If employing contraception, the highly effective methods of contraception detailed in Appendix 1 of the protocol must be followed.","ALL","60 Years",{"count":19,"type":20},380,"ESTIMATED","INTERVENTIONAL",[23],"NA",[25],"Mild Cognitive Impairment","RECRUITING","2026-06-17",{"date":29,"type":30},"2026-06-18","ACTUAL",{"date":32,"type":30},"2024-05-24",{"date":34,"type":20},"2027-12-15",{"name":36,"class":37},"Société des Produits Nestlé (SPN)","INDUSTRY",28,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":62,"leadSponsor":64,"locationsCount":4},"100640328","growth-tolerance-and-functional-biomarkers-in-healthy-infants-receiving-dietary-supplements-100640328","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,"14 Days","28 Days",{"count":50,"type":20},327,[23],"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",[54],"Healthy Infants",[56],"Dietary Supplement","NOT_YET_RECRUITING","2026-06-01",{"date":60,"type":30},"2026-06-05",{"date":58,"type":20},{"date":63,"type":20},"2028-08-31",{"name":36,"class":37},{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":46,"sex":72,"minAge":73,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},"100638360","fiber-nutritional-supplement-for-management-of-constipation-during-pregnancy-100638360","NCT07588633","Fiber Nutritional Supplement for Management of Constipation During Pregnancy","Effectiveness of Daily Supplementation of a Fiber Nutritional Supplement (Materna® Opti-fiber) and Counselling for Constipation Management in Pregnancy","Inclusion Criteria:\n\n1. Pregnant women aged 21 years-old or above at recruitment\n2. Gestational age of 13-27 weeks at recruitment\n3. Singleton pregnancy at recruitment\n4. Suffering from functional constipation according to the Cullen 2007 criteria which must include ALL the following and the criteria must be fulfilled for at least two weeks with symptom onset during pregnancy:\n\n   1. Low frequency of stool (\\\u003C3\u002Fweek)\n   2. Hard stools\n   3. Difficulty on evacuation\n5. Able to understand and to sign a written Informed Consent Form (ICF) prior to study enrolment.\n6. Willing and able to comply with the requirements for participation in this study\n7. Willing and able to refrain from consuming other supplements containing fiber, prebiotics, or probiotics other than the Fiber Nutritional Supplement (Materna® Opti-fiber) over the intervention period\n8. Able to respond to questionnaires in English\n\nExclusion Criteria:\n\n1. Treated for constipation less than one week before the start of the study\n2. Use of prebiotics or probiotics containing supplements two weeks prior to the study start\n3. Major complications during pregnancy e.g., pre-eclampsia, gestational diabetes requiring insulin intervention, severe intra-uterine growth restriction (IUGR), fetal anomalies that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial\n4. Pre-existing medical conditions e.g., hypertension, diabetes mellitus, thyroid diseases, autoimmune diseases such as Systemic Lupus Erythematosus, antiphospholipid syndrome and other major chronic illness that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial\n5. Not willing and\u002For not able to comply with the study procedures and requirements\n6. Known serious food allergy\n7. Known or suspected history of allergy or intolerance to the investigational product (IP)\n8. Active participation in another clinical trial or on-going observational study\n9. Family or hierarchical relationships with the research team members","FEMALE","21 Years",{"count":75,"type":20},31,[23],"This study aims to evaluate the effectiveness of a daily Fiber Nutritional Supplement (Materna® Opti fiber), containing partially hydrolyzed guar gum (PHGG) and vitamins C, D, zinc, and selenium, combined with nutritional counselling, for the management of constipation during pregnancy. Constipation is a common gastrointestinal complaint in pregnancy and may negatively affect quality of life and well being.\n\nThe study is designed as an open label, single arm intervention conducted in pregnant women between 13 and 27 weeks of gestation who meet the Cullen 2007 criteria for functional constipation. A total of 31 participants are planned for enrolment. Eligible participants will receive one sachet per day of the Fiber Nutritional Supplement (Materna® Opti fiber), providing approximately 5.8 g of PHGG, for a duration of 4 weeks. In addition to the investigational product, all participants will receive standardized constipation counselling at baseline, including education on constipation, lifestyle measures.",[79],"Functional Constipation (FC)",[81,82,83],"constipation","fiber","pregnancy","2026-05-11",{"date":86,"type":30},"2026-05-15",{"date":88,"type":20},"2026-05-08",{"date":90,"type":20},"2026-10-08",{"name":36,"class":37},1,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":46,"sex":16,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"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":103,"type":20},172,[23],"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.",[54],[56],"2026-04-23",{"date":110,"type":30},"2026-04-24",{"date":112,"type":20},"2026-06",{"date":114,"type":20},"2027-12",{"name":36,"class":37},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":46,"sex":16,"minAge":122,"maxAge":17,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":92},"100626752","the-effects-of-an-oral-nutritional-intervention-on-the-small-intestine-microbiome-100626752","NCT07439718","The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome","Inclusion Criteria:\n\n1. Males or females aged 18 to 60 years, inclusive, at enrollment.\n2. BMI of ≥18.5 but \\\u003C30 kg\u002Fm2.\n3. Healthy, as determined based on self-reported medical history.\n4. No planned change in diet or medical interventions during the study.\n5. Willing to collect fecal samples and retrieve sampling capsules from feces.\n6. Able to understand and to sign a written informed consent prior to study enrollment.\n7. Willing and able to comply with the requirements for participation in this study.\n\nExclusion Criteria:\n\n1. Prior or suspected gastrointestinal disease (as reported by the participant) which, in the investigator\u002Fstudy doctor's opinion, would lead to fistula formation, intestinal stricturing, or obstruction leading to a risk of capsule non-excretion (i.e. achalasia, active ulcer disease, eosinophilic esophagitis, Crohn's disease, ulcerates colitis, celiac disease, irritable bowel syndrome, stenosis of the GI tract).\n2. Any prior gastrointestinal surgery (as reported by the participant) which, in the investigator\u002Fstudy doctor's opinion, would lead to intestinal stricturing or obstruction leading to a risk of capsule non-excretion (i.e. previous esophageal, gastric, small intestinal, or colonic surgery). Note: appendectomy, cholecystectomy, hysterectomy, oophorectomy, hemorrhoid surgery more than 3 months prior to enrollment are acceptable.\n3. History of chronic diarrhea (defined as Bristol stool scale 5 to 7; or persistent or recurrent loose or watery stools lasting for more than 4 weeks), as reported by the participant.\n4. History of chronic constipation (defined as having less than 3 bowel movements per week) in the past month, as reported by the participant.\n5. Any history of obstructive symptoms in the previous 3 months prior to enrollment, as reported by the participant.\n6. Diagnosis of any organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome, as reported by the participant.\n7. Diagnosis of any malabsorption disorder (i.e. malabsorption syndrome, lactose malabsorption), as reported by the participant.\n8. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule, as reported by the participant.\n9. Any concurrent cancer diagnosis, as reported by the participant.\n10. Any cancer treatment within the past year, as reported by the participant.\n11. History of known abdominal or pelvic radiation treatment at any time in the past, as reported by the participant.\n12. Any cardiovascular, endocrine, renal, liver, or other chronic disease likely to affect motility (i.e. diabetes mellitus, concurrent biliary tract stones, kidney stones, etc.), as reported by the participant.\n13. Antibacterial\u002Fantifungal therapy in the past 3 months prior to enrolment, as reported by the participant.\n14. Use of any medications or supplements that could substantially alter gastrointestinal acidity, motor function, or microbiota (e.g. proton pump inhibitors, H2 receptor antagonists, opioids, prokinetics, anticholinergics, laxatives) in the past 4 weeks prior to enrollment, as reported by the participant.\n15. Underwent colon cleanse or bowel preparation in the 2 weeks prior to enrollment, as reported by the participant.\n16. Scheduled for an MRI at any time during the study duration. Potential participants may be eligible to participate once their MRI procedure is completed.\n17. Females of childbearing age who are pregnant or lactating, as reported by the participant (should an X-ray be required for confirmation of capsule passage; a urine pregnancy test will be administered beforehand).\n18. Alcohol intake higher than 2 servings per day over a week (for males), or more than 1 serving per day over a week (for females), as reported by the participant. A serving is 0.3 dl of strong alcohol, 1 dl of wine, or 3 dl of beer.\n19. Currently participating in another interventional study.\n20. Family or hierarchical relationships with the research team members.","18 Years",{"count":124,"type":20},25,[23],"This is a single-center, single-arm study, aiming at enrolling 25 healthy adult participants to evaluate chronic effects of oil. Specifically, we aim to assess the impact on gut microbiome after a one-month intervention with oil.",[128,129],"Microbiome Composition","Microbiome","2026-04-21",{"date":132,"type":30},"2026-04-22",{"date":134,"type":30},"2026-02-23",{"date":136,"type":20},"2026-05-31",{"name":36,"class":37},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100622014","vegetarian-tube-feed-study-100622014","NCT07378111","Vegetarian Tube Feed Study","Acceptability (Including Gastrointestinal Tolerance, Compliance) of a Vegetarian Paediatric Enteral Tube Feed With Food Derived Ingredients.","Tube feed","Inclusion Criteria:\n\n* Patients from 1 -15 years requiring more than 50% of energy from tube feeding or to take alongside home-made blended diet as part of their dietary management for disease related malnutrition.\n* Patients well-established and stable on current nutritional support regimen. Willingly given, written, informed consent from patient\u002Fcaregiver\n\nExclusion Criteria:\n\n* No established tube feed.\n* Inability to comply with the study protocol, in the opinion of the investigator.\n* Under 1 years of age\n* Patients on parenteral nutrition\n* Known food allergies, including to any ingredients listed in appendix 1.\n* Participation in another interventional study within 2 weeks of this study.\n* Patients with known or suspected ileus or mechanical bowel obstruction","1 Year","15 Years",{"count":124,"type":20},[23],"This is a single arm, prospective, single-centre study to evaluate the gastrointestinal tolerance and compliance over a 28-day period using a tube feed with food derived ingredients.",[152],"Paediatric","2026-03-11",{"date":155,"type":30},"2026-03-12",{"date":157,"type":20},"2026-03-30",{"date":159,"type":20},"2026-12-22",{"name":36,"class":37},{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":170,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":182,"locationsCount":92},"100609138","acceptability-gastrointestinal-tolerance-compliance-and-palatability-study-100609138","NCT07210658","Acceptability, Gastrointestinal Tolerance, Compliance and Palatability Study.","Acceptability (Including Gastrointestinal Tolerance, Compliance and Palatability) of a Paediatric Oral Nutritional Supplement Containing Food Blends.","Inclusion Criteria:\n\n* Patients from 1-15 years requiring 1 or more oral nutritional supplement to replace current oral nutritional supplement as part of their dietary management for disease related malnutrition.\n* Patients well-established and stable on current nutritional support regimen.\n* Willingly given, written, informed consent from patient\u002Fcaregiver.\n\nExclusion Criteria:\n\n* Unsafe swallow\n* Inability to comply with the study protocol, in the opinion of the investigator.\n* Under 1 years of age\n* Patients on total parenteral nutrition\n* Known food allergies, including any allergies to the ingredients\n* Patients with Chronic Kidney Disease (CKD) stage 3b (G3b), stage 4 (G4), stage 5 (G5) or hepatic impairment.\n* Participation in another interventional study within 2 weeks of this study.\n* Patients with known or suspected ileus or mechanical bowel obstruction","16 Years",{"count":124,"type":20},[23],"Acceptability, compliance and palatability study.",[173],"Paediatrics",[175],"Acceptability","2026-01-08",{"date":178,"type":30},"2026-01-09",{"date":180,"type":30},"2025-04-14",{"date":86,"type":20},{"name":36,"class":37},{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":146,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":21,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},"100619195","acceptability-and-tolerance-study-of-bolus-tube-feed-with-food-blends-100619195","NCT07341464","Acceptability and Tolerance Study of Bolus Tube Feed With Food Blends","Acceptability (Including Gastrointestinal Tolerance and Compliance) of a Paediatric and Adult Bolus Tube Feed With Food Blends","Blends","Inclusion Criteria:\n\n* Patients from 1 -15 years for children and 15 years and above for adults of requiring 1 or more bolus tube feed alongside their usual tube feed or home-made blended diet as part of their dietary management for disease related malnutrition.\n* Patients well-established and stable on current enteral tube feed or home-made blended diet.\n* Gastrostomy fed only.\n* Willingly given, written, informed consent from patient\u002Fcaregiver\n\nExclusion Criteria:\n\n* Inability to comply with the study protocol, in the opinion of the investigator.\n* Under 1 years of age\n* Patients who have a nasogastric and jejunal feeding tubes\n* Patients on total parenteral nutrition\n* Known food allergies to any ingredients listed in appendix 1.\n* Patients with significant renal or hepatic impairment\n* Participation in another interventional study within 2 weeks of this study.\n* Patients with known or suspected ileus or mechanical bowel obstruction",{"count":192,"type":20},50,[23],"This is a prospective acceptability study to evaluate the gastrointestinal tolerance and compliance of a bolus tube feed over a 28 -day period for up to 50 participants.\n\nThe enteral bolus formula is for the dietary management of patients with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, and disease related malnutrition.",[196,197],"Cerebral Palsy (CP)","Oncology","2026-01-06",{"date":200,"type":30},"2026-01-14",{"date":202,"type":30},"2025-12-10",{"date":204,"type":20},"2026-11-11",{"name":36,"class":37},2,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":46,"sex":16,"minAge":214,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":21,"phases":217,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":206},"100617429","effects-of-staged-adapted-inclusions-in-infant-cereals-on-oral-motors-patterns-of-6-24-month-old-children-100617429","NCT07318506","Effects of Staged Adapted Inclusions in Infant Cereals on Oral-motors Patterns of 6-24 Month-old Children","ICONIC","Inclusion Criteria:\n\n1. Children between 6 months (182 days) to 24 months (730 days) of age (from enrollment to last visit):\n\n   1.1. \\[182-242\\]-days of age from V1 to last visit for the 6-8-month-old age group 1.2. \\[243-364\\]-days of age from V1 to last visit for the 8-12-month-old age group 1.3. \\[365-547\\]-days of age from V1 to last visit for the 12-18-month-old age group 1.4. \\[548-730\\]-days of age from V1 to last visit for the 18-24-month-old age group\n2. Singleton, full-term infants (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.\n3. Healthy children based on medical history as reported by parent(s) \u002F LAR(s).\n4. Sit upright with or without support (such as, sitting with back against a chair or while being held) as reported by parent(s) \u002F LAR(s)\n5. Keep head steady when in a supported position\n6. Have already started complementary feeding as recommended by their health care professional (have started solid food beyond breastmilk or infant formula)\n7. Written informed consent is obtained from at least one parent(s) \u002F LAR(s).\n8. Parent(s) \u002F LAR(s) must be able to provide evidence of parental authority and identity.\n9. Parent(s) \u002F LAR(s) must understand the informed consent and other study documents.\n10. Parent(s) \u002F LAR(s) are willing and able to fulfill the requirements of the study protocol within the study timeframe.\n\nExclusion Criteria:\n\n* 1\\. Infant's parents or LARs have not reached legal age of majority (18 years) 2. Children with history of oral\u002Ffacial malformations or surgery (i.e. cleft lip, cleft palate, tongue-tie\u002Fankyloglossia), or history of tube feeding for any reason.\n\n  3\\. Children with any chronic illness, congenital malformations (e.g., esophageal or intestinal atresia), surgical sequela (e.g., short bowel syndrome), gastroesophageal reflux disease, behavioral disorders, neurodevelopmental delay or illness that impacts feeding. \\[children with an acute illness, such as a cold, gastroenteritis etc. can be included but can only attend the visits once they have recovered\\].\n\n  4\\. Children with feeding or swallowing difficulties\u002Fdisorders, history of choking, or at high risk of choking.\n\n  5\\. Child or sibling(s) who has known or suspected food allergy or intolerance, such as cows' milk protein allergy, celiac disease, lactose intolerance, soy allergy, fish allergy, or any other suspected or confirmed food allergies or intolerance.\n\n  6\\. Children with undernutrition as determined by age-group weight threshold (based on parental reports): weight at \\[6-8\\[month \\\u003C 6 kg; weight at \\[8-12\\[months: \\\u003C 6.5 kg; weight at \\[12-18\\[months: \\\u003C 7.5 kg; weight at \\[18-24\\] months: \\\u003C 8.5 kg.\n\n  7\\. Child is currently participating in or has participated in another intervention clinical study that impacts study outcomes within 4 weeks prior to enrolment or has participated in another age group of this study.\n\n  8\\. Family or hierarchical relationships with the research team members.","6 Months",{"count":216,"type":20},153,[23],"The purpose of this study is to define the effects of different inclusions in infant cereals on the adaptation of oral motor behavior and skills displayed at a given age.",[220,221],"Healthy","Infant and Young Child Feeding","2025-12-18",{"date":198,"type":30},{"date":225,"type":30},"2025-11-05",{"date":227,"type":20},"2026-05",{"name":36,"class":37},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":237,"enrollmentInfo":238,"targetDuration":4,"studyType":21,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":251},"100564751","effect-of-a-hydrolyzed-rice-protein-based-formula-on-growth-tolerance-and-health-related-quality-of-life-in-infants-with-cows-milk-protein-allergy-100564751","NCT06633250","Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy.","Effect of a Hydrolyzed Rice Protein-based Formula on Growth, Tolerance, and Health-related Quality of Life in Infants With Cow's Milk Protein Allergy: a Randomized Nutritional Clinical Study","RIGHT-GO","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \\[LAR\\]), if applicable)\n2. Infant gestational age ≥ 37 completed weeks\n3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg\n4. Singleton birth\n5. Infant age ≤ 8 months\n6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk\n7. Suspected CMPA as per standard clinical practice and in conjunction with at least 2 symptoms present from the list shown below:\n\n   1. Inconsolable crying, regurgitation, liquid stools or constipation, skin atopic lesion, cow's milk provoked temporary urticaria\u002Fangioedema or vomiting, bloody streaks in stool, or respiratory symptoms\n   2. For diagnosis based on either a positive IgE blood test, skin prick test or food challenge, only at least 1 symptom from above list needs to be present\n8. Infant is receiving a strict cow's milk elimination diet and will continue receiving this diet until the completion of the study\n9. Infant's parent(s)\u002FLAR is of legal age of majority, must have parental authority, must understand the informed consent form and other study documents, and is willing and able to fulfill the requirements of the study protocol\n\nExclusion Criteria:\n\n1. History of intolerance to eHF formula\n2. Any chronic medical diseases (except atopic eczema), chromosomal or major congenital anomalies (based on medical history and\u002For commonly performed diagnostic criteria)\n3. Major gastrointestinal disease \u002F abnormalities (other than CMPA)\n4. Known or suspected lactose intolerance or malabsorption\n5. Known or suspected soy allergy\n6. Glucose-galactose malabsorption\n7. Rice protein allergy or intolerance (e.g., rice protein-induced enterocolitis syndrome).\n8. Immunodeficiency\n9. Persistent wheeze or chronic respiratory disease\n10. Severe uncontrolled eczema\n11. History of severe anaphylactic reaction (e.g., requiring ≥ 2 doses of epinephrine) to cow's milk or breast milk at any time prior to enrollment\n12. Weight-for-age value \\\u003C -2 or \\> 2 standard deviations from the WHO Child Growth Standards median at enrollment\n13. Height-for-age \\\u003C -2 or \\> 2 standard deviations from the WHO Child Growth Standards median at enrollment\n14. Infant's parent has other medical or psychiatric condition that, in the judgement of the investigator, would make the infant inappropriate for entry into the study\n15. Currently participating or having participated in another interventional clinical study within 4 weeks prior to enrollment","8 Months",{"count":239,"type":20},104,[23],"The main purpose of this study is to demonstrate that the growth of infants fed with the Test Formula is non-inferior those fed with the Control Formula. The study will also evaluate the gastrointestinal tolerance, quatliy of life and acceptability of the new rice protein-based formula in infants with cow's milk protein allergy (CMPA).",[243],"Cow Milk Protein Allergy",{"date":245,"type":30},"2025-12-26",{"date":247,"type":30},"2024-10-25",{"date":249,"type":20},"2026-08",{"name":36,"class":37},19,{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":46,"sex":16,"minAge":259,"maxAge":48,"enrollmentInfo":260,"targetDuration":4,"studyType":21,"phases":262,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"100505978","effect-of-partially-hydrolyzed-whey-based-infant-formulas-on-growth-and-tolerability-in-healthy-term-infants-100505978","NCT05868408","Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants","Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \\[LAR\\]), if applicable)\n2. Infant gestational age ≥37 completed weeks\n3. Infant birth weight of ≥2.5 kg and ≤4.5 kg\n4. Singleton birth\n5. Infant postnatal age ≤28 days (date of birth = day 0)\n6. Mother has previously decided to fully formula-feed, and infant is no longer breastfeeding or receiving breast milk\n7. Infant's parent(s)\u002FLAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol\n\nExclusion Criteria:\n\n1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth\n2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)\n3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia or gestational diabetes)\n4. Infants with special dietary needs other than standard infant formula\n5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance\u002Fallergy, or lactose intolerance or severe food allergies that impact diet\n6. Child has other medical or psychiatric condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study\n7. Currently participating or having participated in another interventional clinical trial prior to enrollment","0 Days",{"count":261,"type":20},234,[23],"This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.",[265,266,267,268,269],"Infant Nutritional Physiological Phenomena","Infant Formula","Infant Health","Infant Development","Growth and Development",{"date":271,"type":30},"2025-12-19",{"date":273,"type":30},"2023-08-17",{"date":275,"type":20},"2028-06",{"name":36,"class":37},3,{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":46,"sex":16,"minAge":285,"maxAge":286,"enrollmentInfo":287,"targetDuration":4,"studyType":21,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":4},"100616944","oral-nutritional-supplementation-in-children-with-growth-concerns-100616944","NCT07312201","Oral Nutritional Supplementation in Children With Growth Concerns","Oral Nutritional Supplementation in Children With Growth Concerns: A Randomized, Controlled Single-blinded Study","Inclusion Criteria:\n\n* Child's parent(s) is of legal age of majority (18 years of age), must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol.\n* Evidence of a personally signed and dated informed consent document indicating that the child's parent(s) \u002F legally acceptable representative (LAR) has been informed of all pertinent aspects of the study.\n* Child was full-term at birth (i.e., ≥ 37 completed weeks of gestation with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg).\n* Child is aged 24 - 41 months at inclusion.\n* Child is generally healthy (acute illnesses in a minor condition which are common in childhood such as viral or bacterial infections (e.g., conjunctivitis, otitis media, upper\u002Flower respiratory tract infection, gastroenteritis, hand foot \\& mouth disease) at time of enrolment is permitted).\n* Children whose parents, caregivers, or guardians show some concern about their child's dietary intakes and growth, such as child is too thin for his or her height, or child has experienced recent rapid weight loss or failure to gain weight or height and child has a z-score for weight-for-age or weight-for-height or both parameters ≤ -1SD as per WHO growth charts.\n* Child's parents agree to feed their child an oral nutritional supplement in addition to normal diet.\n* Child's parent(s) \u002F guardian can be contacted directly by telephone throughout the study.\n\nExclusion Criteria:\n\n* Child is currently breastfed or is consuming breast milk.\n* Child is currently consuming or consumed in the past month growing-up milk \u002F toddler formula. Growing-up milks \u002F toddler formulas are products specifically formulated for young children and provide key macro- and micro-nutrients.\n* Child is currently consuming or consumed in the past month oral nutrition supplement (ONS). The standard ONS formula has an energy density of at least 0.85 kcal\u002FmL, containing protein, carbohydrate and\u002For fat, as well as a wide range of micronutrients to supplement or use as the sole source of nutrition.\n* Child has known or suspected cows' milk protein intolerance \u002F allergy, lactose intolerance, galactosemia, soy intolerance \u002F allergy, fish oil intolerance \u002F allergy, or allergy or intolerance to any ingredient in the study product.\n* Child fed vegan, vegetarian, or vegetarian plus fish diets in which milk products are excluded.\n* Underlying medical illness that could affect growth or feeding, such as gastrointestinal \\[GI\\] disorders (such as celiac disease, short bowel syndrome, maldigestion\u002Fmalabsorption, significant GI malformations or surgery etc.); neurodevelopmental disability; chronic infections (such as tuberculosis or HIV infection); congenital disease or genetic disorders (such as congenital cardiac disease, Down syndrome, thalassemia); or other chronic illness that may impact growth or feeding according to the clinician opinion.\n* Child is unable to consume foods or ONS orally (e.g. dysphagia, anorexia, difficulty in swallowing due to acquired or congenital abnormalities that would hamper oral intake of the study product.)\n* Clinically significant nutritional deficiency requiring specific nutritional therapy other than the study product (for example tube feeding)\n* Child has acute illness including acute viral infection, respiratory tract infection etc. even in a minor condition at time of enrolment. A child presenting with an acute illness can be re-screened at least two weeks after the episode of illness has resolved.\n* Child has a z-score for weight-for-height or weight-for-age or height-for-age or any combination of these three parameters ≤ -3SD as per WHO growth charts.\n* Children currently receiving or having received prior to enrolment medication which are known to impact growth including systemic steroids, growth hormone and insulin\n* Child or child's parent(s) not willing and\u002For not able to comply with scheduled visits and\u002For have plans to relocate to a different geographical location from the study location during the study period.\n* Child of any investigational site staff member or Nestlé employee directly involved in the conduct of the trial.\n* Child is currently participating in or has participated in another clinical trial within 4 weeks prior to enrolment.","24 Months","41 Months",{"count":288,"type":20},216,[23],"Multi-center, single-blinded, randomized, controlled study consisting of two arms, to investigate the impact of an oral nutritional supplement in combination with dietary counseling on growth in children with growth concerns as compared to children who receive dietary counselling alone",[292,293,294,295],"Growth","Toddlers","Attention","Cognitive Function","2025-12-16",{"date":298,"type":30},"2025-12-31",{"date":300,"type":20},"2026-09-30",{"date":302,"type":20},"2028-05-31",{"name":36,"class":37},{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":310,"eligibilityCriteria":311,"healthyVolunteers":46,"sex":16,"minAge":312,"maxAge":47,"enrollmentInfo":313,"targetDuration":4,"studyType":21,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":327},"100588597","effect-of-partially-hydrolyzed-formula-with-synbiotics-on-skin-barrier-function-100588597","NCT06943469","Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function","Synbiotics in Partially Hydrolysed Formula for Improved skiN Barrier Function in Infants at Risk for Allergy (SPHINX Study)","SPHINX","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable\n2. Infant gestational age ≥ 37 completed weeks\n3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg\n4. Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment\n5. Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.\n6. At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire\n7. a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of age.\n\n   or b. For the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. The decision to introduce formula feeding was independently made by the parents before enrollment.\n8. Parents\u002FLAR must be able to provide evidence of parental authority and identity.\n9. Infant's parent(s)\u002FLAR must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.\n2. Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding.\n3. Infant has already been diagnosed with allergy by a physician, including AD and\u002For cow's milk allergy.\n4. Infant is currently participating or has previously participated in another clinical trial prior to enrollment.\n5. Infant's parents or LARs have not reached legal age of majority (18 years).","1 Day",{"count":314,"type":20},400,[23],"The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.",[318],"Atopic Dermatitis (AD)","2025-12-11",{"date":321,"type":30},"2025-12-12",{"date":323,"type":30},"2025-04-10",{"date":325,"type":20},"2028-11",{"name":36,"class":37},23,{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":46,"sex":16,"minAge":335,"maxAge":4,"enrollmentInfo":336,"targetDuration":4,"studyType":338,"phases":4,"briefSummary":339,"conditions":340,"keywords":346,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":92},"100611611","evaluation-of-the-effect-of-seasonality-on-biological-age-in-adults-100611611","NCT07242833","Evaluation of the Effect of Seasonality on Biological Age in Adults","SeasonAGE","Inclusion Criteria:\n\n1. Males and females aged over 40 years, inclusive, at enrolment.\n2. Assessed by the investigator to be in general good health or have stable, well-controlled chronic medical conditions (e.g. hypertension, type 2 diabetes, etc.) that are not expected to interfere with study participation or outcomes. (Note: stable medical condition is defined as controlled medical condition, with no change in medication, worsening of the condition, or hospitalization in the past 3 months prior to enrolment).\n3. Body mass index (BMI) ≥18.5 kg\u002Fm².\n4. Able to understand and to sign a written informed consent prior to study enrolment.\n5. Willing and able to comply with the requirements for participation in this study.\n\nExclusion Criteria:\n\n1. Any past or on-going significant medical\u002Fsurgical condition and\u002For psychiatric condition, which in the opinion of the investigator may risk participant's wellbeing\u002Fsafety, impede participant compliance with study procedures or ability to complete the study and\u002For could confound the primary objectives of the study (such as seasonal allergy).\n2. Any acute illness or any recent medical\u002Fsurgical intervention, including vaccination, within 21 days prior to enrolment.\n3. Female participants who are pregnant or intending to become pregnant, lactating and\u002For breastfeeding\n4. Currently participating in another interventional research study.\n5. Family or direct hierarchical relationship with the research team members.","40 Years",{"count":337,"type":20},60,"OBSERVATIONAL","This research aims to provide insights on how seasonal variations influence biological age and enhance the design and analysis of long-term lifestyle interventions targeting biological clocks.\n\nAging is a gradual decline in cellular and organ functions, significantly increasing the risk of non-communicable and infectious diseases. Recent research has focused on identifying aging biomarkers that can better predict functional capability in healthy individuals. Biological age clocks, which can be measured from samples like blood or saliva, are emerging as valuable tools for assessing the pace of aging and calculating age acceleration-the difference between chronological and biological age.\n\nThese clocks utilize molecular and clinical data, including DNA methylation and plasma proteomics, to predict future health outcomes, such as disease risk and mortality. Various DNA methylation-based clocks have been developed, with the Dunedin Pace of Aging (PoAm) offering a more precise modeling of physiological changes over time. Lifestyle factors, including diet and physical activity, can influence age acceleration, suggesting that lifestyle interventions may impact biological aging.\n\nCurrent evidence indicates that three specific epigenetic clocks-PhenoAge, GrimAge, and Dunedin PACE-are particularly effective in detecting beneficial effects on aging trajectories. However, the stability of these clocks during long-term lifestyle interventions remains unclear, as they can exhibit variability over short periods and may be affected by factors influenced by seasonal changes, such as Vitamin D levels, climate, and white blood cells composition.\n\nTo investigate these seasonal effects on biological age, a proposed observational study will track changes over a 12-month period in middle-aged and older adults.",[341,342,343,344,345],"Aging","Aging, Biological","Aging, Healthy","BIOLOGICAL CLOCKS","Biological Clock Disturbance",[347,348,349,350],"aging","biological age","biological clock","lifestyle","2025-12-03",{"date":202,"type":30},{"date":354,"type":30},"2025-11-24",{"date":356,"type":20},"2027-08",{"name":36,"class":37},{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":259,"maxAge":47,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":367,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":383},"100532409","feeding-tolerance-and-growth-of-preterm-infants-consuming-a-supplement-containing-two-human-milk-oligosaccharides-hmos-100532409","NCT06212427","Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs)","Feeding Tolerance and Growth of Preterm Infants Consuming a Supplement Containing Two Human Milk Oligosaccharides (HMOs): A Post-Market Study","Inclusion Criteria:\n\n1. Written informed consent has been obtained from at least one parent (or other legally acceptable representative \\[LAR\\], if applicable)\n2. Infant's parent(s)\u002FLAR is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol\n3. Infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound\n4. Infant birth weight ≤ 2500g\n5. Infant postnatal age ≤ 14 days\n6. Infant has tolerated trophic feeds (e.g., 10-15 mL\u002Fkg\u002Fday) for at least 24 hours but has not yet reached full enteral feeding\n\nExclusion Criteria:\n\n1. Infant is clinically unstable, for example:\n\n   1. Infant has hemodynamic instability as evidenced by clinical signs of sepsis, hypotension (MAP \\\u003C 5th percentile for age for at least three hours), or is receiving vasopressor drugs\n   2. Infant has received an exchange transfusion within the past 48 hours\n   3. Infant has had an episode of severe asphyxia at birth (PH less than 7.0)\n   4. Infant has signs of necrotizing enterocolitis according to modified Bell staging criteria (stage IIA or higher)\n2. Major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, Turner syndrome)\n3. Infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study\n4. Participation in another interventional clinical study that may interfere with the results of this study",{"count":366,"type":20},188,[23],"The goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (HMOs), 2'-fucosyllactose \\[2'FL\\] and lacto-N-neotetraose \\[LNnT\\], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.\n\nA comparison with data collected retrospectively from a historical group at each site will be made for time to reach full enteral feeding, growth and adverse events. Infants in the historical group were not exposed to an HMO supplement but followed the same local nutrition protocol to avoid confounding by differences in clinical or feeding practice.",[370,371],"Premature Infant","Low Birthweight Infant",[373,374,292],"Human Milk Oligosaccharides","Feeding tolerance","2025-12-01",{"date":377,"type":30},"2025-12-08",{"date":379,"type":30},"2023-11-20",{"date":381,"type":20},"2026-02-28",{"name":36,"class":37},6,{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":46,"sex":16,"minAge":391,"maxAge":47,"enrollmentInfo":392,"targetDuration":4,"studyType":21,"phases":394,"briefSummary":395,"conditions":396,"keywords":397,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":92},"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":393,"type":20},262,[23],"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.",[54],[373,398,399,400,292,401],"Infant gut microbiota","Infant gut health","Immune response","Tolerance","2025-11-26",{"date":404,"type":30},"2025-11-28",{"date":406,"type":30},"2024-07-29",{"date":408,"type":20},"2027-06",{"name":36,"class":37},{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":46,"sex":16,"minAge":416,"maxAge":417,"enrollmentInfo":418,"targetDuration":4,"studyType":338,"phases":4,"briefSummary":419,"conditions":420,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":423,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":92},"100432864","a-first-ever-research-collaboration-to-characterize-mri-measured-neural-flexibility-development-in-chinese-toddlers-100432864","NCT04916652","A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers","Inclusion Criteria:\n\n1. Written informed consent has been obtained from the parent\u002Flegally acceptable representative.\n2. Full-term birth (≥ 37 weeks and ≥ 2.5kg)\n3. Typically developing Children aged between 32-34 months (2 years 8 months to 2 years10 month of age) at enrolment\n4. Neurotypical development as assessed by interview\n5. No major risk factors for learning, neurologic, or psychiatric disorder as assessed by interview \\[defined as a diagnosed learning neurologic or psychiatric disorder in a first degree relative (e.g. parents, siblings)\\].\n6. Dietary requirement detailed below:\n\nS-26 GOLD or ULTIMA GUM--fed group:\n\nI. Daily consumption of S-26 GOLD or ULTIMA GUM for the last 60 days (2 months) II. Desire of the parent to continue feeding GUM during the course of the study\n\nCow's milk-fed group:\n\nI. Daily consumption of cow's milk or for the last 60 days (2 months) II. Desire of the parent to continue feeding cow's milk during the course of the study\n\nExclusion Criteria:\n\n1. Delayed birth ( \\> 41 weeks gestation) as reported in medical record\n2. Birth Weight \\\u003C 2500 g or small for gestational age (birth weight below the 10th percentile) or large for gestational age (birth weight above the 90th percentile) as reported in medical record\n3. History of neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in the toddler as assessed by interview\n4. History of diagnosed neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in parents or siblings, as assessed by interview\n5. In utero exposure to alcohol abuse or illicit substances as defined as diagnosis of current substance use disorder in the biological mother and guidelines set by the American College of Obstetricians and Gynecologists and the Royal College of Physicians\n6. Multiple birth as reported in medical record\n7. Complicated pregnancy (e.g., preeclampsia, gestational diabetes) as assessed by medical interview\u002F medical record\n8. Abnormal screening laboratory values and studies considered to be clinically significant in the opinion of the Investigator (e.g., metabolic disease screening, neonatal bilirubin)","32 Months","34 Months",{"count":337,"type":20},"The overall objective is to characterize the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, in Chinese toddlers (32 to 42 months old).",[421,422],"Growth & Development","Brain",{"date":351,"type":30},{"date":425,"type":30},"2024-04-06",{"date":427,"type":20},"2027-02",{"name":36,"class":37},""]