Crohn DiseaseNCT07383597
Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Ulcerative Colitis and Crohn Disease
A study testing Efferon LPS in people with Crohn Disease and Ulcerative Colitis, run by Efferon JSC at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- Efferon LPS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 1 Mar 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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]).
- Alcohol or drug dependence.
- Any other condition that, in the investigator's opinion, would preclude the patient's participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
North-Western State Medical University named after I.I. Mechnikov
Saint Petersburg
Igor Bakulin, PhD, MD, +7 812-303-50-60, igbakulin@yandex.ru
About this study
Official title: 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.
Read the detailed description
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.
- Being tested
- Efferon LPS
- Keywords
- Hemoadsorption, Hemoperfusion, Extracorporeal therapy, LPS adsorption
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efferon LPSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Efferon LPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-90 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 1-90 days
Hospital length of stay
Time (days) from enrollment to hospital discharge
Measured: 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.
Measured: 1-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Efferon JSC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Igor Bakulin, PhD, MD, Principal investigator, North-Western State Medical University named after I.I.Mechnikov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383597
- Sponsor's protocol ID
- efferon-lps-2025-04
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pilot Study of LPS Adsorption Using the Efferon LPS Device in Patients With Ulcerative Colitis and Crohn's Disease During Disease Exacerbation
- ClinicalTrials.gov ID
- NCT07383597
- Acronym / sponsor ID
- efferon-lps-2025-04
- Keywords
- Hemoadsorption, Hemoperfusion, Extracorporeal therapy, LPS adsorption
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Efferon JSCIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Baseline therapy | No intervention | –These patients will receive standard therapy for Crohn disease or ulcerative colitis |
| Baseline therapy + Efferon LPS | Experimental | Device: Efferon LPSThese patients will receive standard therapy for Crohn disease or ulcerative colitis and Efferon LPS hemoadsorption. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efferon LPSEfferon 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. | Device | Baseline therapy + Efferon LPS |
Primary outcome
Change in the Crohn's Disease Activity Index (CDAI) score
Time frame: 1-90 days
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.
Change in the Mayo score in patients with ulcerative colitis
Time frame: 1-90 days
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.
4 secondary outcomes
Change in the Simple Endoscopic Score for Crohn's Disease (SES-CD)
Time frame: 1-90 days
Change in the Endoscopic Activity Index for Ulcerative Colitis (Schroeder Score)
Time frame: 1-90 days
Hospital length of stay
Time frame: 1-90 days
The Inflammatory Bowel Disease Questionnaire (IBDQ) index
Time frame: 1-90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Igor Bakulin, PhD, MD principal investigator
North-Western State Medical University named after I.I.Mechnikov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Efferon LPS in people with Crohn Disease and Ulcerative Colitis, run by Efferon JSC at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandr Shelehov-Kravchenko, PhD, MD (+79636564765, alexandr.shelehov@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Crohn's Disease Activity Index (CDAI) score (time frame: 1-90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.