Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT05931458 Sponsor: Federico II University Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT05931458
Not Yet Recruiting Not Applicable

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 aged 18 or older.
  • People who have been definitively diagnosed with left-sided ulcerative colitis (a form of bowel inflammation affecting the left side of the colon, up to about the middle of the large intestine).
  • People whose disease has not responded to standard treatments and who have been identified as candidates for a type of medication called anti-TNF-alpha therapy.
  • People who have agreed to undergo the surgical procedure involved in this trial.

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 under the age of 18.
  • People whose diagnosis of ulcerative colitis is uncertain, or where Crohn's disease cannot be ruled out.
  • People who have previously had their appendix removed.
  • People who have previously had open abdominal surgery (a large surgical cut through the abdomen) that could make the appendix removal more complicated.
  • People with a very severe flare-up of colitis or a dangerous complication called toxic megacolon (a serious swelling of the large intestine).
  • People who have not agreed to take part in the surgical procedure.
  • People who, during the operation, need to have a different procedure performed instead of appendix removal due to unexpected complications.
  • People who are pregnant.

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 30 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: Gaetano Luglio, Prof, Federico II University

Phone: 00390817462775

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
Federico II University
Registry
ClinicalTrials.gov
Start date
1 July 2023
Est. completion
1 July 2024

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Primary endpoints

Steroid Free Clinical Remission; Steroid Free Clinical Remission; Endoscopic remission; Endoscopic remission; Assessment of Quality of Life; Assessment of Quality of Life; Assessment of Quality of Life; Assessment of Quality of Life

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: 30 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