Blood filtering device for ulcerative colitis and Crohn disease flare-ups
Tests the Efferon LPS blood filter in adults with ulcerative colitis or Crohn disease.
Plain-language title generated from the registry record
Registry title: Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Ulcerative Colitis and Crohn Disease
Key facts
- Where
- Saint Petersburg, RussiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07383597, who can take part
Where in Russia
- North-Western State Medical University named after I.I. MechnikovSaint Petersburg, RussiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Efferon JSC
- Trial code
- NCT07383597
- Record updated
- 11 February 2026
- Original description
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.Read full original descriptionShow less
A Randomized Pilot Study of LPS Adsorption Using the Efferon LPS Device in Patients With Ulcerative Colitis and Crohn's Disease During Disease Exacerbation
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.
Participants 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.
Inclusion: 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.
Exclusion: 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; 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; 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.