Crohn's Disease and Colitis Trial, Recruiting NCT05561738 Sponsor: University of Pittsburgh Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT05561738
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:

  • Children and teenagers aged 18 or younger
  • People who have been diagnosed with mild to moderate ulcerative colitis, based on a standard activity score (called PUCAI) and results from a colonoscopy
  • People who have been recently diagnosed with ulcerative colitis and have not yet received treatment, as well as those who have had the condition for a longer period of time

Who may not be able to join:

  • People who have a severe, acute (sudden and serious) form of ulcerative colitis
  • People who currently have a gastrointestinal infection, such as C. difficile or cytomegalovirus
  • People who have been diagnosed with Crohn's disease
  • People who have been diagnosed with indeterminate colitis or a condition called IBD-U (where the type of inflammatory bowel disease is unclear)
  • People who have used steroids or antibiotics in the past three months — though people on biologic medications (a type of specialist treatment) may be considered if their dose has been stable for at least three months; the treating doctor makes the final decision on eligibility
  • People who have other long-term inflammatory or autoimmune conditions, or who have previously had cancer
  • Women who are pregnant, or women of childbearing age who are not using contraception at the time of joining
  • People who have existing kidney or liver problems
  • People whose platelet count (a measure in a blood test) is below 50,000, as this means a colonoscopy cannot be safely performed, which is required for the trial

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 27 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: Kevin Mollen, University of Pittsburgh

Phone: 412-692-6272

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
Not Applicable
Registry
ClinicalTrials.gov
Start date
28 February 2024
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Number of patients screened; Proportion of patients screened who meet inclusion/exclusion criteria; Enrollment percentage; Completion percentage; Reasons for exclusion; Dropout rate; Reasons for dropout

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: 27 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