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

ConditionsCrohn DiseaseUlcerative ColitisInflammatory Bowel Diseases
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Baseline therapyNo intervention 0 interventions
Group B: Baseline therapy + Efferon LPSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1-90 days
2

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.

Time frame
1-90 days

Secondary outcomes

1

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

The Simple Endoscopic Score for Crohn's Disease (SES-CD) is an endoscopic index reflecting Crohn disease activity.The score is calculated as the sum of multiple endoscopic parameters assessed across different intestinal segments. Disease activity is classified as follows: 0-2 points - mucosal healing; 3-6 points - minimal activity; 7-15 points - moderate activity; ≥16 points - severe activity.

Time frame
1-90 days
2

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

The endoscopic activity index for ulcerative colitis according to Schroeder (endoscopic Mayo subscore) is used to assess the severity of mucosal inflammation based on colonoscopic findings. The score ranges from 0 to 3 points, with higher values indicating greater endoscopic disease activity. A score of 0 corresponds to normal or inactive disease, a score of 1 indicates mild inflammatory changes, a score of 2 reflects moderate inflammation, and a score of 3 is characteristic of severe endoscopic activity with pronounced mucosal damage.

Time frame
1-90 days
3

Hospital length of stay

Time (days) from enrollment to hospital discharge

Time frame
1-90 days
4

The Inflammatory Bowel Disease Questionnaire (IBDQ) index

The Inflammatory Bowel Disease Questionnaire (IBDQ) is a validated disease-specific instrument used to assess health-related quality of life in patients with inflammatory bowel disease. It consists of 32 items grouped into four domains: bowel symptoms, systemic symptoms, emotional function, and social function. Each item is scored on a 7-point Likert scale, resulting in a total score ranging from 32 to 224 points, with higher scores indicating better quality of life. Changes in the IBDQ score over time reflect improvements or deterioration in patient-reported outcomes and overall well-being.

Time frame
1-90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Efferon JSC

Lead sponsor

Source ClinicalTrials.gov

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