Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT06071312 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

NCT06071312
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:

  • You are 18 years of age or older
  • You have active ulcerative colitis (UC) with symptoms that are at least moderately active, based on a standard scoring system
  • You have a recurring Clostridioides difficile (C. diff) infection — meaning the infection has come back more than once
  • You are able to understand and sign a consent form to participate in the study
  • Your doctor has already decided, as part of your normal care, that you should receive a fecal microbiota transplant (a treatment using stool from a healthy donor) for your recurring C. diff infection

Who may not be able to join:

  • You are under 18 years of age
  • You have another gut infection (other than C. diff)
  • You have another active digestive or gut condition besides ulcerative colitis, such as celiac disease, irritable bowel syndrome, chronic pancreatitis, or a gut infection caused by other sources
  • You have previously had surgery on your colon or have a stoma (a surgically created opening on the abdomen for waste)
  • You have any known food allergies
  • You are currently taking, or have taken in the last 2 weeks, certain medications that can affect gut bacteria — such as antibiotics (other than those treating C. diff), probiotics, proton pump inhibitors (like omeprazole), immunosuppressants, or metformin
  • You have heart failure or a heart condition where your heart is pumping at a very low capacity (confirm with trial site)
  • You have severe breathing or respiratory problems
  • You have a diagnosed psychiatric (mental health) disorder
  • You are currently pregnant or breastfeeding
  • You are unable to give informed consent to take part 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.

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 26 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, MD, 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
23 September 2023
Est. completion
24 September 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Number of UC patients who will obtain the eradication of rCDI 8 weeks after treatments (single FMT vs sequential FMT)

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: 26 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