[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622436":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":12,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":12,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":12,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":80,"whyStopped":12,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Efferon JSC","INDUSTRY",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Baseline therapy","NO_INTERVENTION","These patients will receive standard therapy for Crohn disease or ulcerative colitis",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Baseline therapy + Efferon LPS","EXPERIMENTAL","These patients will receive standard therapy for Crohn disease or ulcerative colitis and Efferon LPS hemoadsorption.",[18],"Device: Efferon LPS",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DEVICE","Efferon LPS","Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity.\n\nHemoadsorption was administered in 3-4 sessions of at least 2 hours each via peripheral vascular access, with intervals of no more than 5 days between sessions.",[14],[26],{"name":27,"affiliation":28,"role":29},"Igor Bakulin, PhD, MD","North-Western State Medical University named after I.I.Mechnikov","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":12,"email":35},"Alexandr Shelehov-Kravchenko, PhD, MD","CONTACT","+79636564765","alexandr.shelehov@gmail.com",[37],{"facility":38,"status":12,"city":39,"state":12,"zip":12,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"North-Western State Medical University named after I.I. Mechnikov","Saint Petersburg","Russia","RU",{"type":43,"coordinates":44},"Point",[45,46],30.31413,59.93863,{"lat":46,"lon":45},[49],{"name":27,"role":33,"phone":50,"phoneExt":12,"email":51},"+7 812-303-50-60","igbakulin@yandex.ru",{"type":53,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100622436","lipopolysaccharide-adsorption-efferon-lps-in-patients-with-ulcerative-colitis-and-crohn-disease-100622436",false,"NCT07383597","Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Ulcerative Colitis and Crohn Disease","A Randomized Pilot Study of LPS Adsorption Using the Efferon LPS Device in Patients With Ulcerative Colitis and Crohn's Disease During Disease Exacerbation","Inclusion Criteria:\n\n* Crohn's disease (ICD-10: K50), extensive disease, with a chronic continuous or relapsing course during an exacerbation (flare), including:\n\n  * Severe flare: CDAI ≥ 450 and\u002For SES-CD \\> 15;\n  * Moderate flare: CDAI 350-450 and\u002For SES-CD \\> 7, steroid-refractory.\n* Ulcerative colitis (ICD-10: K51), with a chronic continuous or relapsing course during an exacerbation (flare), including:\n\n  * Severe flare: Mayo score ≥ 10 and partial Mayo score ≥ 6;\n  * Moderate flare: Mayo score 6-9 and partial Mayo score ≥ 3, steroid-refractory or steroid-dependent.\n* Presence of signs and symptoms of ulcerative colitis or Crohn's disease for at least 3 months prior to study enrollment.\n* The diagnosis must be confirmed by clinical and endoscopic findings and supported by a histopathology report\n* The patient's condition allows Efferon LPS therapy to be performed for at least 2 hours\n\nExclusion Criteria:\n\n* Indeterminate colitis, radiation colitis, ischemic colitis,confirmed presence of megacolon, strictures, or stenosis causing symptoms of intestinal obstruction.\n* Expected need for bowel resection within 4 weeks after enrollment\n* Presence at hospitalization of a stoma, ileal pouch-anal anastomosis, or a fistula with purulent discharge (which, in the investigator's opinion, is likely to require surgical or medical intervention within 4 weeks after enrollment), or planned ileostomy or colostomy.\n* Partial or total colectomy, small bowel resection, or creation of a stoma (i.e., temporary or permanent colostomy, ileostomy, or other enterostomy) within 6 months prior to enrollment, or presence of an external or entero-enteric fistula with symptoms within 6 months prior to enrollment.\n* Suspected or diagnosed intra-abdominal or perianal abscess that has not been adequately treated.\n* Positive test for Clostridioides difficile toxin.\n* Positive test for infectious pathogens (including helminth eggs, parasites, or bacterial infections).\n* History of malignancy within the past 5 years, including solid tumors or hematologic malignancies (except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin in situ, or cervical dysplasia\u002Fcancer that has been surgically excised with complete resolution), or colonic mucosal dysplasia that has not been completely removed.\n* End-stage renal disease.\n* Acute pulmonary embolism confirmed by imaging.\n* Acute myocardial infarction within the last 4 weeks.\n* Acute cerebrovascular accident (stroke) within the last 8 weeks.\n* Dementia.\n* Uncontrolled bleeding (acute blood loss within the last 24 hours).\n* History or current evidence of recurrent or chronic viral infection (e.g., hepatitis B virus, hepatitis C virus, or human immunodeficiency virus \\[HIV\\]).\n* Alcohol or drug dependence.\n* Any other condition that, in the investigator's opinion, would preclude the patient's participation in this study.","ALL","18 Years","65 Years",{"count":65,"type":66},40,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoperfusion using the Efferon® LPS device in patients with ulcerative colitis and Crohn disease.\n\nParticipants will be assigned to two groups for comparison: a control group receiving baseline therapy and a treatment group receiving baseline therapy in combination with Efferon® LPS hemoadsorption.",[72,73,74],"Crohn Disease","Ulcerative Colitis","Inflammatory Bowel Diseases",[76,77,78,79],"Hemoadsorption","Hemoperfusion","Extracorporeal therapy","LPS adsorption","NOT_YET_RECRUITING","2026-02-09",{"date":83,"type":84},"2026-02-11","ACTUAL",{"date":86,"type":66},"2026-03-01",{"date":88,"type":66},"2028-03-01",{"name":5,"class":6},1]