Blood filter device aims to tame severe IBD flares
NCT ID NCT07383597
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a blood-filtering device called Efferon LPS in 40 adults with Crohn's disease or ulcerative colitis during a flare-up. The device is designed to remove harmful substances from the blood to reduce inflammation. Participants will either receive standard care alone or standard care plus the blood-filtering treatment. The goal is to see if the device can safely help control disease activity during a flare.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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 \[HIV\]). * Alcohol or drug dependence. * Any other condition that, in the investigator's opinion, would preclude the patient's participation in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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North-Western State Medical University named after I.I. Mechnikov
Saint Petersburg, Russia
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Other studies related to the condition(s) this trial covers.
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