Crohn's Disease and Colitis Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People diagnosed with Crohn's disease that is widespread, with a pattern of ongoing or recurring flare-ups, and who are currently experiencing either a severe flare (based on specific disease activity scores) or a moderate flare that has not responded to steroid treatment.
- People diagnosed with ulcerative colitis, with a pattern of ongoing or recurring flare-ups, and who are currently experiencing either a severe flare or a moderate flare that has not responded to or relies heavily on steroid treatment (based on specific disease activity scores).
- People who have had signs and symptoms of ulcerative colitis or Crohn's disease for at least 3 months before joining the study.
- People whose diagnosis has been confirmed through clinical assessment, endoscopy, and a tissue sample (biopsy) report.
- People whose current health allows them to undergo the study treatment (Efferon LPS therapy) for at least 2 hours.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People with indeterminate colitis, radiation colitis, or ischemic colitis, or who have a confirmed enlarged colon (megacolon), narrowing or blockages in the bowel causing obstruction symptoms.
- People who are expected to need bowel removal surgery within 4 weeks of joining the study.
- People who have a stoma, a surgically created internal pouch, or a fistula with infected discharge at the time of hospitalisation, or who have planned stoma surgery — where the investigator believes surgery or significant treatment is likely to be needed within 4 weeks.
- People who have had part or all of their colon removed, had small bowel surgery, or had a stoma created within the 6 months before enrolling, or who have had a fistula with symptoms within that same period.
- People with a suspected or confirmed abscess inside the abdomen or around the anal area that has not been properly treated.
- People who have tested positive for a bacterial toxin called Clostridioides difficile (a type of gut infection).
- People who have tested positive for infectious organisms, including intestinal worms, parasites, or bacterial infections.
- People who have had a cancer diagnosis in the past 5 years, including solid tumours or blood cancers — with some exceptions for certain minor skin conditions or cervical conditions that have been fully removed and resolved (confirm with trial site).
- People with end-stage kidney disease.
- People with a recent confirmed blood clot in the lungs (pulmonary embolism), confirmed by imaging.
- People who have had a heart attack within the past 4 weeks.
- People who have had a stroke within the past 8 weeks.
- People living with dementia.
- People with uncontrolled bleeding or significant blood loss within the past 24 hours.
- People with a history of, or currently living with, a recurring or chronic viral infection such as hepatitis B, hepatitis C, or HIV.
- People with alcohol or drug dependence.
- People with any other condition that, in the investigator's opinion, would prevent safe participation in the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Igor Bakulin, PhD, MD, North-Western State Medical University named after I.I.Mechnikov
Phone: +79636564765
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in the Crohn's Disease Activity Index (CDAI) score; Change in the Mayo score in patients with ulcerative colitis
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.