Crohn'sUCNot yet recruiting

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

Not applicable · Testing Efferon LPS · 1 site · Efferon JSC

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

This study is testing Efferon LPS (a device) as a possible treatment. Condition(s) listed: Crohn Disease, Ulcerative Colitis and Inflammatory Bowel Diseases.

Participants are assigned to groups by chance (randomized).

It is open-label: participants know what they are receiving.

This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).

Who can join

Ages 18 to 65
Any sex

Some of the main requirements, copied from the record:

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.

Plus 6 more requirement(s). There are also 17 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

About 40 participants are expected to take part.
Start date: 2026-03-01 (planned).
Main results expected around 2027-09-01 (estimate from the record).
1 study site listed in Russia.

Main thing being measured

Change in the Crohn's Disease Activity Index (CDAI) score (1-90 days)

In the researchers’ words

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.

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Am I likely to qualify, given my health history?
What would I have to do, and how often would I need to visit?
Could I get a placebo? What happens to my current treatment?
What are the possible risks and benefits?
Are travel or other costs covered?
What happens after the trial ends?

Official details

Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional
Conditions	Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Diseases
Lead sponsor	Efferon JSC
Enrollment	40 (estimated)
Start date	2026-03-01
Primary completion (est.)	2027-09-01
First posted	2026-02-03
Last updated	2026-02-11
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

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.

Full eligibility criteria (from the record)

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.

Locations (1)

Site	City	Country	Site status
North-Western State Medical University named after I.I. Mechnikov	Saint Petersburg	Russia

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.