[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460204":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":62,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":25,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":25,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":25,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"FFT treatment","EXPERIMENTAL","Treatment with fecal filtrate transfer in saline solution administered by nasogastric tube",[13],"Other: Fecal Filtrate Transfer",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Treatment","PLACEBO_COMPARATOR","Treatment with saline solution administered by nasogastric tube",[19],"Other: Placebo",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Fecal Filtrate Transfer","Treatment with donated fecal samples filtered to contain practically no bacteria and mainly viruses, including bacteriophages",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Saline solution",[15],[31],{"name":32,"affiliation":5,"role":33},"Lise Aunsholt, md, phd","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Gustav R Jakobsen, md","CONTACT","+4550569536","gustav.riemer.jakobsen@regionh.dk",{"name":32,"role":37,"phone":41,"phoneExt":25,"email":42},"+4561991137","lise.aunsholt@regionh.dk",[44],{"facility":45,"status":46,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Rigshospitalet","RECRUITING","Copenhagen","2100","Denmark","DK",{"type":52,"coordinates":53},"Point",[54,55],12.56553,55.67594,{"lat":55,"lon":54},[58,60],{"name":59,"role":37,"phone":38,"phoneExt":25,"email":39},"Gustav R Jakobsen, Medical doctor",{"name":61,"role":37,"phone":41,"phoneExt":25,"email":42},"Lise Aunsholt, MD, ph.d., professor",{"type":33,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Gustav Riemer Jakobsen","Medical Doctor, Ph.d-student",[66],{"name":67,"class":68},"Lise Aunsholt, Neonatologist, Clinical Professor","UNKNOWN","100460204","early-phase-1-prephage---faecal-bacteriophage-transfer-for-enhanced-gastrointestinal-tract-maturation-in-preterm-infants-100460204",false,"NCT05272579","PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants","PrePhage - Faecal Bacteriophage Transfer for Enhanced Gastrointestinal Tract Maturation in Preterm Infants - Clinical Trial","Inclusion criteria for participant preterm infants\n\n* Preterm infants born between GA 26+0 and 30+6\n* Delivery at RH or transferred to RH NICU within 24 hours of delivery\n* Children administered prophylactic antibiotics due to maternal risk factors, specifically: premature rupture of membranes, groub b streptococcus positive, feber during labour\n* Signed parental consent\n\nExclusion criteria for participant preterm infants\n\n* Major congenital anomalies or birth defects\n* Antibiotics for more than 72 hours after birthExtremely SGA infant (weight SD score \\\u003C -3 SD)\n* Need for mechanical ventilation or cardiovascular support before first FFT treatment\n\nInclusion criteria for mothers of participants\n\n* Women aged 18-45\n* Ability to give informed consent\n\nExclusion criteria for participant mothers\n\n● Mothers who have severe infection, defined by need for other treatment to support infection-related comorbidities, besides from antibiotics (e.g. inotropic treatment, iv fluid resuscitation)","ALL",{"count":78,"type":79},20,"ESTIMATED","INTERVENTIONAL",[82],"EARLY_PHASE1","PrePhage - Fecal bacteriophage transfer for enhanced gastrointestinal tract maturation in preterm infants\n\nThis pilot triol has the primary goal of demonstrating the safety of transferring viruses and proteins from healthy term infants to preterm infants born between gestational age (GA) 26 + 0 and 30+6. The long-term goal is to develop a safe and effective treatment to prevent the severe gut disease called necrotizing enterocolitis (NEC).\n\nNEC is a common disease in neonatal intensive care units affecting 5-10% of all admitted patients. 15-30% of the affected children die from the disease, and many of the survivors suffer from the effects of extensive gut surgery.\n\nWhile the disease is caused by many different factors, recent research has shown the gut microbiome to be a central factor in the development of NEC. Furthermore, in the recent years special viruses called bacteriophages have shown potential in the treatment of various diseases.\n\nBy collecting feces from healthy, term infants and filtering it thoroughly, the investigators can provide a treatment that contains practically only viruses, proteins and nutrients. It is our belief that giving the preterm infants a mix of viruses including bacteriophages will prevent NEC.\n\nTo do this, the investigators will go through 3 stages:\n\n1. Recruiting and following healthy donor infants to study the microbiota and use feces from them to donate in stage 2 and 3\n2. Examining the safety of the treatment as well as how it works in preterm piglets\n3. Testing the treatment in preterm infants. 10 preterm infants will receive the treatment and 10 preterm infants will receive placebo. The investigators expect to see no serious side effects to the treatment. The investigators hope, but do not expect to be able to see a beneficial effect of the treatment.\n\nIf this pilot trial shows promising results, it will be followed be a larger clinical trial.",[85,86],"Necrotizing Enterocolitis","Microbial Substitution","2024-11-13",{"date":89,"type":90},"2024-11-15","ACTUAL",{"date":92,"type":90},"2023-11-07",{"date":94,"type":79},"2025-12-31",{"name":5,"class":6},1]