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

NCT07383597 | Not Yet Recruiting

• 1 other identifier: efferon-lps-2025-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Keywords

Hemoadsorption; Hemoperfusion; Extracorporeal therapy; LPS adsorption

Outcome Measures

Primary Outcomes (2)

• Change in the Crohn's Disease Activity Index (CDAI) score

  The Crohn's Disease Activity Index (CDAI) is calculated as a composite score based on a set of clinical and laboratory parameters reflecting disease activity. The higher the CDAI score, the greater the clinical activity of Crohn's disease. A CDAI score below 150 corresponds to clinical remission, scores of 150-300 indicate mild disease activity, 301-450 indicate moderate disease activity and a score of 450 points or higher is considered indicative of a severe disease flare.

  1-90 days

• Change in the Mayo score in patients with ulcerative colitis

  The Mayo score is a composite index used to assess disease activity in ulcerative colitis. It includes four components evaluating stool frequency, rectal bleeding, endoscopic findings, and the physician's global assessment. Higher Mayo scores indicate greater severity of ulcerative colitis. Disease activity can be categorized based on the total Mayo score as follows: 0-2 points indicate remission, 3-5 points indicate mild disease, 6-9 points indicate moderate disease, and 10-12 points indicate severe disease.

  1-90 days

Secondary Outcomes (4)

• Change in the Simple Endoscopic Score for Crohn's Disease (SES-CD)

  1-90 days

• Change in the Endoscopic Activity Index for Ulcerative Colitis (Schroeder Score)

  1-90 days

• Hospital length of stay

  1-90 days

• The Inflammatory Bowel Disease Questionnaire (IBDQ) index

  1-90 days

Study Arms (2)

Baseline therapy

NO INTERVENTION

These patients will receive standard therapy for Crohn disease or ulcerative colitis

Baseline therapy + Efferon LPS

EXPERIMENTAL

These patients will receive standard therapy for Crohn disease or ulcerative colitis and Efferon LPS hemoadsorption.

Device: Efferon LPS

Interventions

Efferon LPS DEVICE

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. Hemoadsorption 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.

Baseline therapy + Efferon LPS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (1)

North-Western State Medical University named after I.I. Mechnikov

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Igor Bakulin, PhD, MD

  North-Western State Medical University named after I.I.Mechnikov

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

+79636564765; alexandr.shelehov@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Allocation of patients into groups will be done by stratified 1:1 randomisation. Each group will include an equal number of patients with Crohn's disease (n=10) and ulcerative colitis (n=10).

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 3, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

RU (1)