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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.
Inflammatory bowel diseases (IBD) represent a group of chronic inflammatory disorders, with the main clinical entities being Crohn's disease and ulcerative colitis. The prevalence of IBD is increasing worldwide, imposing a substantial socioeconomic burden on society and healthcare systems.In IBD, in the presence of predisposing genetic factors and unclear triggers, a loss of immunological tolerance to luminal antigens occurs. This results in persistent inflammation of the intestinal wall, leading to mucosal damage and increased permeability of the mucosa to various antigens, which further amplify and sustain the pro-inflammatory immune response. Increased intestinal permeability and subsequent endotoxin translocation may also play a role in the pathogenesis of IBD.
Currently used treatments for IBD aim to control inflammation and modulate mucosal immune responses by blocking cytokine activity, such as tumor necrosis factor (TNF) and Interleukin 23, preventing the homing of immune cells to the gut, or inhibiting T-cell egress from lymph nodes.Steroid-free remission, due to the adverse effects associated with corticosteroids, is one of the primary treatment goals in IBD, whereas long-term corticosteroid use is considered a marker of suboptimal disease control.
Some patients with highly active IBD, who cannot be treated with pharmacological therapy for various reasons (including refractoriness, intolerance, or significant adverse effects), require alternative treatment approaches. Among these, extracorporeal therapy modalities, which have been rapidly developing in recent years, represent a promising therapeutic option.
Compared with standard steroid therapy, extracorporeal treatment modalities demonstrate comparable therapeutic efficacy and safety. In addition, extracorporeal therapies may represent an alternative treatment option for IBD without the undesirable adverse effects associated with systemic corticosteroids, immunosuppressants, and biologic agents. This also applies to hemoadsorption, which has been shown to reduce circulating levels of cytokines, various cytotoxins, myoglobin, and products of cellular breakdown in patients' blood. However, data on the use of cytokine hemoadsorption in IBD are extremely limited, and no published studies have been identified regarding the use of lipopolysaccharide (endotoxin) adsorption in IBD.
The Efferon® LPS device was originally developed for use in sepsis, leveraging its ability to effectively target both primary and secondary inflammatory mediators. This therapeutic approach also holds substantial potential for the treatment of other pathological conditions characterized by complex inflammatory responses.
This study aims 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Crohn's disease (ICD-10: K50), extensive disease, with a chronic continuous or relapsing course during an exacerbation (flare), including:
Ulcerative colitis (ICD-10: K51), with a chronic continuous or relapsing course during an exacerbation (flare), including:
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 Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandr Shelehov-Kravchenko, PhD, MD | Contact | +79636564765 | alexandr.shelehov@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Igor Bakulin, PhD, MD | North-Western State Medical University named after I.I.Mechnikov | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North-Western State Medical University named after I.I. Mechnikov | Saint Petersburg | Russia |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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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).
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|
| 1-90 days |
| 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. | 1-90 days |
| Hospital length of stay | Time (days) from enrollment to hospital discharge | 1-90 days |
| 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. | 1-90 days |
| D003092 | Colitis |
| D003108 | Colonic Diseases |