Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Ulcerative Colitis and Crohn Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEfferon JSC
About this trial
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.
Eligibility criteria
Qualifiers
Severe flare: CDAI ≥ 450 and/or SES-CD > 15;
Moderate flare: CDAI 350-450 and/or SES-CD > 7, steroid-refractory.
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.
Disqualifiers
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
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.
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.
Trial design
Treatments tested in this trial
- Efferon LPS
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov