Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Ulcerative Colitis and Crohn Disease

Prior treatment

• Indeterminate colitis, radiation colitis, ischemic colitis,confirmed presence of megacolon, strictures, or stenosis causing symptoms of intestinal obstruction.
• Expected need for bowel resection within 4 weeks after enrollment
• 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.
• Alcohol or drug dependence.

Other illness

• 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.
• Positive test for infectious pathogens (including helminth eggs, parasites, or bacterial infections).
• 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/cancer that has been surgically excised with complete resolution), or colonic mucosal dysplasia that has not been completely removed.
• End-stage renal disease.
• Acute myocardial infarction within the last 4 weeks.
• Acute cerebrovascular accident (stroke) within the last 8 weeks.
• Dementia.
• Uncontrolled bleeding (acute blood loss within the last 24 hours).
• History or current evidence of recurrent or chronic viral infection (e.g., hepatitis B virus, hepatitis C virus, or human immunodeficiency virus \[HIV\]).
• Any other condition that, in the investigator's opinion, would preclude the patient's participation in this study.

Other

• Suspected or diagnosed intra-abdominal or perianal abscess that has not been adequately treated.
• Positive test for Clostridioides difficile toxin.
• Acute pulmonary embolism confirmed by imaging.

• Crohn's disease (ICD-10: K50), extensive disease, with a chronic continuous or relapsing course during an exacerbation (flare), including:
  • Severe flare: CDAI ≥ 450 and/or SES-CD \> 15;
  • Moderate flare: CDAI 350-450 and/or SES-CD \> 7, steroid-refractory.
• Ulcerative colitis (ICD-10: K51), with a chronic continuous or relapsing course during an exacerbation (flare), including:
  • Severe flare: Mayo score ≥ 10 and partial Mayo score ≥ 6;
  • Moderate flare: Mayo score 6-9 and partial Mayo score ≥ 3, steroid-refractory or steroid-dependent.
• Presence of signs and symptoms of ulcerative colitis or Crohn's disease for at least 3 months prior to study enrollment.
• The diagnosis must be confirmed by clinical and endoscopic findings and supported by a histopathology report
• The patient's condition allows Efferon LPS therapy to be performed for at least 2 hours