[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jakob Stokholm\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100536391","phase-1-restoration-of-the-gut-microbiome-after-cesarean-section-100536391",false,"NCT06264219","Restoration of the Gut Microbiome After Cesarean Section","\"Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)\" - A Double-blinded Randomized Placebo-controlled Trial","RestoreGut","Inclusion Criteria:\n\n* Gestational age \\\u003C week 38+0 days\n* Proficient in spoken\u002Fwritten Danish\n* Single pregnancy (no twins or triplets)\n* Pre-pregnancy BMI between 18.5 and 35 kg\u002Fm2\n* No chronic intestinal, endocrine, cardiac, or kidney disorders\n* No known gestational complications (gestational diabetes, preeclampsia, gestational hypothyroidism)\n* No regular use of prescription medication or any drugs that, in the research team's opinion, may interfere with the study's results.\n* Willingness to abstain from giving the child products with probiotics (fermented dairy like yogurt or A38 are allowed).\n\nExclusion Criteria:\n\nMaternal:\n\n* Use of antibiotics within one month of stool donation\n* Acute gastroenteritis within one month of stool donation\n* Use of antibiotics within one month of birth\n* Time since last travel abroad relative to data of fecal donation according to the requirements for blood donations (\"Regler for tappepauser\" - blooddonor.dk)\n* Positive test results for pathogens during donor material screening.\n* Antibiotic treatment at birth (vaginal births only)\n* Spontaneous onset of labor or emergency cesarean section before scheduled cesarean section.\n\nInfant:\n\n* Instances of major birth defects or intrauterine growth retardation (IUGR)\n* Infants requiring pediatric support at the time of transplant administration",true,"FEMALE","18 Years",{"count":21,"type":22},80,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. The Study will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section.",[28],"Microbial Colonization","RECRUITING","2026-06-25",{"date":32,"type":33},"2026-06-29","ACTUAL",{"date":35,"type":33},"2024-08-02",{"date":37,"type":22},"2027-08-30",{"name":39,"class":40},"Jakob Stokholm","OTHER",2,""]