[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microbiome-human\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microbiome-human":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,54,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":36,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100617272","birth-cohort-development-of-ige-autoantibodies-in-newborns-with-high-risk-of-atopic-dermatitis-100617272",false,"NCT07316465","Birth Cohort: Development of IgE Autoantibodies in Newborns With (High Risk of) Atopic Dermatitis","Development of IgE Autoantibodies in Newborns With Atopic Dermatitis (DIANA) Birth Cohort","DIANA","Inclusion Criteria:\n\nNewborns who are planned to be born at the maternity ward of UZ Brussel with the following criteria:\n\n* 400 newborns with high-risk for AD-development (at least 1 parent or sibling with physician diagnosed atopic dermatitis AND\u002FOR asthma AND\u002FOR allergic rhinitis)\n* 100 newborns with low-risk for AD-development (no parents or siblings with history of atopic dermatitis AND\u002FOR asthma AND\u002FOR allergic rhinitis)\n\nExclusion Criteria:\n\n* Newborns not born at the maternity ward of UZ Brussel\n* Parents with a poor understanding of Dutch, French or English\n* Newborns who are admitted post-partum to the neonatal intensive care unit (gestational age \\\u003C34 weeks) or with medical complications\n* Newborns with severe genetic abnormalities\u002Fbirth defects\n* Newborns whose parents will not be able to attend the study visits for a period of 2 years (location, working hours)",true,"ALL","1 Hour","24 Months",{"count":22,"type":23},500,"ESTIMATED","INTERVENTIONAL",[26],"NA","Previous research has shown that some patients with atopic eczema have specific self-reactive antibodies, known as IgE autoantibodies, that react to their own skin cells, referred to as \"self-reactive antibodies\" or \"autoantibodies\". It is not yet known when and how these self-reactive antibodies develop, so this is what we aim to investigate.\n\nThis study aims to examine the presence of self-reactive antibodies at birth. In other words, the investigators want to study the earliest stage of developing antibodies that target the body's own skin cells. Additionally, factors that contribute to the development of these self-reactive antibodies will be explored as well as the correlation with the development of atopic eczema.\n\nThe study will involve newborns who are at an increased risk of developing atopic eczema due to a family history of asthma, hay fever, or atopic eczema. There will also be a control group of newborns without these characteristics. The study's approach is to examine a portion of the umbilical cord blood, which is routinely collected after birth, to investigate self-reactive antibodies. The goal is to determine whether these self-reactive antibodies are linked to the development of atopic eczema in the first two years of life. For this purpose, follow-ups will be conducted at the ages of 6, 12, and 24 months.\n\nThis study will contribute to an increased understanding of the prevalence of self-reactive antibodies and the factors influencing their development. Moreover, the study will determine whether these antibodies play a role in the prevention of and\u002For serve as predictive factors for the development of atopic eczema.",[29,30,31,32,33,34,35],"Atopic Dermatitis (AD)","Autoantibody","Auto-Immunity","Microbiome, Human","Allergic Disease","IgE-Mediated Hypersensitivity","Newborn Infant",[37,38,39,40,15],"Birth cohort","Autoantibodies","IgE","Atopic dermatitis","RECRUITING","2025-12-18",{"date":44,"type":45},"2026-01-05","ACTUAL",{"date":47,"type":45},"2023-10-01",{"date":49,"type":23},"2030-12-31",{"name":51,"class":52},"Universitair Ziekenhuis Brussel","OTHER",1,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":24,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":53},"100577163","phase-2-a-probiotic-based-intervention-in-pregnancies-complicated-by-gdm-100577163","NCT06794723","A Probiotic Based Intervention in Pregnancies Complicated by GDM","A Single-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of a Probiotic-based Intervention to Improve Glycemic Control in Pregnancies Complicated by Gestational Diabetes.","ProbioGDM","Inclusion Criteria:\n\nParticipants must meet all the following inclusion criteria to be eligible for enrollment into the study:\n\n1. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n2. Participant has given written consent after study has been explained according to local regulatory requirements and before any study specific procedures.\n3. Age ≥16 years at the time of consent.\n4. Singleton pregnancy.\n5. Live fetus (documented positive fetal heartbeat prior to recruitment)\n6. Diagnosis of Gestational Diabetes (GDM) at the time of inclusion (documented 50g glucose challenge test (\\>11.1 mmol\u002FL) and\u002For 75g oral glucose tolerance test with results exceeding the normal range (fasting \\>5.3 mmol\u002FL, 1 hour \\>10.6 mmol\u002FL, or 2 hour \\> 8.9 mmol\u002FL)\n7. Willing to provide fecal swab samples.\n8. Willing to wear a continuous glucose monitor from enrollment until delivery and for 14 days at 6 weeks postpartum.\n9. Willing to provide results from the continuous glucose monitor using the associated app on their mobile device.\n10. Willing to complete surveys related to diet, pregnancy history, and health history.\n11. Plan to reside in the study area at least until delivery and to deliver at Kingston Health Sciences Center (KHSC).\n12. Willing to test for Group B Strep during pregnancy\n\nExclusion Criteria:\n\nAny individual meeting any of the following criteria is not eligible for participation in this study:\n\n1. Current diagnosis of severe gestational hypertension, preeclampsia, HELLP, intrauterine growth restriction, or other clinically significant pregnancy complication(s) at the time of enrollment.\n2. Sustained use of substances, such as alcohol, cannabis, nicotine, and other recreational drugs. This is defined as any use after the patient is aware that they are pregnant OR as per the discretion of the investigator.\n3. Systemic antibiotic or antifungal use ≤3 months prior to enrollment.\n4. Active clinical infection(s), such as sexually transmitted infections, urinary tract infectionss, systemic infections, periodontal disease or positive blood cultures ≤3 months prior to enrollment\n5. Acute or chronic clinically significant abnormality or poorly controlled pre-existent co-morbidities, such as autoimmune disease, inflammatory bowel disease (IBD), Crohn's, colitis, or other conditions, that, in the opinion of the investigator, might confound study results.\n6. Prescription medications, especially relating to gastric function, or immunosuppressants, that, in the opinion of the investigator, might confound study results.\n7. Known hypersensitivity to \\>4 first-line antimicrobial therapies against Akkermansia muciniphila, Clostridium beijerinckii, Clostridium butyricum, Anaerobutyricum hallii: Penicillin, Piperacillin, Tetracycline, Amoxicillin, Ampicillin.\n8. Known hypersensitivity to \\>4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin.\n9. Any conditions that, in the Investigator's judgement, may interfere with participant's ability to comply with study procedures or receipt of prenatal care, such as behavioural or cognitive impairment or neuropsychiatric illness.\n10. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine\u002Fproduct.\n11. Pill swallowing phobia or inability to swallow pills.\n12. Not taking any other probiotic supplements during the study intervention period.","FEMALE","16 Years",{"count":65,"type":23},173,[67],"PHASE2","This study is a single center randomized control trial of a probiotic based intervention in pregnancies complicated by gestational diabetes. A healthy gut microbiome is now recognized as a key component of human health and dysbiosis of the gut microbiome, including lack of diversity, is believed to contribute to the development of many diseases and alter glucose control. The study aims to explore whether this probiotic intervention will improve glucose control and change the gut microbiome. Participants may be enrolled and randomized after diagnosis of gestational diabetes between 24 and 31 weeks gestation. 115 participants will be randomized in a ratio of 2 in the probiotic intervention group to 1 in the placebo group. Participants will stop taking the intervention at 6 weeks postpartum. At this time, they will be unblinded and offered the option of participating in an open-label extension of the intervention until 6 months postpartum.",[70,32],"Gestational Diabetes Mellitus (GDM)",[72,73,74,75,76],"Microbiome","Gestational Diabetes","Probiotic","Glucose Control","Pregnancy","NOT_YET_RECRUITING","2025-06-03",{"date":80,"type":45},"2025-06-06",{"date":82,"type":23},"2025-10-01",{"date":84,"type":23},"2029-12-31",{"name":86,"class":52},"Queen's University",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":18,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":98,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":106,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":53},"100587006","between-the-belly-and-the-brain-distorted-gut-brain-crosstalk-in-early-life-adversity-100587006","NCT06922773","Between the Belly and the Brain: Distorted Gut-brain Crosstalk in Early-life Adversity","BellyBrain","Inclusion Criteria:\n\n* Primary school-aged children (6 to 13 years of age) who have experienced at least one early-life traumatic event, based on the Childhood Trust Events Survey (CTES) questionnaire\n* The child and at least one of his\u002Fher parents (or guardian) speak Dutch sufficiently well to complete all of the questionnaires and the semi-structured child psychiatric interview (SCID-5-Junior)\n\nExclusion Criteria:\n\n* any chronic disorders or diseases known to affect the gut micobiome\n* inablity to complete questionnaires and\u002For semi-structured interview because of linguistic and\u002For cognitive barrier\n* congenital or acquired immunodeficiencies\n* use of medication(s) that affect gastrointestinal function (e.g., antibiotics) within the last 6 weeks, or laxatives within the last 4 weeks, or probiotic or prebiotic supplements within the last 4 weeks\n* current involvement in another clinical or food study","6 Years","13 Years",{"count":97,"type":23},50,"1 Month","OBSERVATIONAL","The goal of this observational study is to learn about the effects of early-life adversity (ELA) on the composition of children's microbiome and on their psychosocial functioning. The main questions it aims to answer are:\n\n* Do children who have experienced ELA have lower gut microbial diversity and\u002For an altered gut microbial composition?\n* Do these microbiome alterations correlate with adverse neurodevelopmental outcomes, including increased levels of stress, social and\u002For affective problems?",[102,32,103,104,105],"Early Life Adversity","Anxiety Symptoms","Depressive Symptoms","Posttraumatic Stress Symptoms",[107,108,109,110,111],"early life adversity","gut microbiome","anxiety symptoms","depressive symptoms","posttraumatic stress symptoms","2025-04-03",{"date":114,"type":45},"2025-04-10",{"date":116,"type":23},"2025-05",{"date":118,"type":23},"2026-06",{"name":51,"class":52}]