Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT06569888 Sponsor: Istituto Clinico Humanitas Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT06569888
Not Yet Recruiting Not Applicable

Who may 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 might be able to join this trial:

Phase A (active disease group):

  • You are 18 years old or older
  • You have been diagnosed with ulcerative colitis (UC) for at least 3 months
  • Your UC is currently moderately to severely active, based on a standard scoring system
  • Your doctor has recommended starting a targeted treatment for your UC, but you have not begun it yet
  • If you are taking steroid tablets (like prednisone), your dose has been stable for at least 3 weeks and is no higher than 20 mg per day
  • You are scheduled for a colonoscopy to check your disease activity as part of your normal care
  • You are able to follow all the study procedures
  • Your Body Mass Index (BMI) is below 23

Phase B (remission group):

  • You are 18 years old or older
  • You have been diagnosed with UC and your disease is currently in remission (well controlled) while on a targeted therapy
  • You are able to follow all the study procedures
  • Your BMI is below 23

Who may not be able to join:

  • You have been diagnosed with a different type of colitis, such as Crohn's, microscopic, ischemic, infectious, or radiation-related colitis
  • You have a medical reason why a colonoscopy would not be safe for you, or you had serious complications during a previous colonoscopy
  • You have a bleeding disorder
  • You need surgery for your UC
  • You do not have the legal capacity to give consent for yourself
  • You have used rectal treatments (enemas or suppositories) within the 2 weeks before the study starts
  • You have been taking more than 20 mg of prednisone within the 3 weeks before the study starts
  • You have low levels of haemoglobin (a measure of anaemia) at the start of the study
  • You are pregnant or breastfeeding
  • You have an implanted contraceptive device (such as a coil/IUD)
  • Your BMI is above 23
  • You have been diagnosed with cancer, especially bowel or rectal cancer
  • You have a type of osteoporosis involving very rapid bone loss (confirm with trial site)
  • You have metal fragments in your body
  • You have joint replacements (prostheses)
  • You have varicose veins
  • You have a condition involving inflamed veins (phlebitis or thrombophlebitis)
  • You have a pacemaker fitted
  • You have a serious condition affecting blood flow in the arteries (obliterating arteriopathy) (confirm with trial site)
  • You are currently menstruating at the time of the study procedure
  • You have cancerous tissue or are near an area being treated for cancer
  • You have tuberculosis
  • You are a child or adolescent still in a growth phase
  • You are unable to communicate or describe feelings of pain
  • The study doctor considers you unsuitable to participate for any other reason

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Alessandro Armuzzi, MD, Istituto Clinico Humanitas

Phone: 02 8224 2488

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

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Istituto Clinico Humanitas
Registry
ClinicalTrials.gov
Start date
1 November 2024
Est. completion
30 October 2025

Primary endpoints

Efficiency of LIPUS in terms of target-specific extracellular vesicle release

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov