Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT05739864 Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT05739864
Recruiting Phase 2

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:

  • People aged between 18 and 75 years old
  • People diagnosed with mild to moderate Ulcerative Colitis, confirmed by a specific scoring system used by doctors, who have been on stable treatment for a set period (more than 4 weeks on a type of anti-inflammatory bowel medication, or more than 6 weeks on immune-suppressing or biologic medications)
  • People who received their Ulcerative Colitis diagnosis less than 12 months ago
  • People who are able to provide written consent to participate
  • People who are able to attend and follow the scheduled study visits and procedures

Who may not be able to join:

  • People under 18 years old
  • People with other known active digestive or gut conditions, such as a gut infection, coeliac disease, Crohn's disease, irritable bowel syndrome, chronic pancreatitis, or a condition causing bile-related diarrhoea
  • People who have previously had surgery on the large bowel or have a stoma (an opening on the abdomen for waste removal)
  • People currently taking, or who have taken in the last 2 weeks, certain medications that may affect gut bacteria — such as antibiotics, probiotics, a type of acid-reducing medication, or a diabetes medication called metformin
  • People with severe heart failure or a heart condition where the heart is pumping at a very low capacity
  • People with severe breathing difficulties
  • People with a diagnosed psychiatric disorder
  • People who are pregnant or breastfeeding
  • People who are unable to provide written informed consent

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
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Gianluca Ianiro, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phone: +39 0630157338

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
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
13 February 2023
Est. completion
14 February 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Number of patients who will obtain remission of disease 8 weeks after treatments

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