Phase 4 Crohn's Disease and Colitis Trial, Recruiting NCT06774079 Sponsor: University of Miami Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, Recruiting

NCT06774079
Recruiting Phase 4

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 a confirmed diagnosis of Crohn's disease
  • Your Crohn's disease is considered mildly active, based on a specific symptom scoring system called the Harvey Bradshaw Index, with a score between 5 and 7
  • Your Body Mass Index (BMI, a measure of body weight relative to height) is 27 or above
  • You are currently on a stable dose of a type of medication called anti-TNF therapy (a medication that targets inflammation)

Who may not be able to join:

  • You are under 18 years of age
  • You have ulcerative colitis (a different type of bowel condition)
  • You have an infection-related form of bowel inflammation
  • Your BMI is below 27
  • You have type 1 or type 2 diabetes
  • You have a personal or family history of a specific type of thyroid cancer (medullary thyroid cancer) or a condition called Multiple Endocrine Neoplasia syndrome type 2 (confirm with trial site)
  • You are already taking a type of medication known as a GIP/GLP-1 receptor agonist (examples include tirzepatide or semaglutide)
  • You regularly experience severe constipation, nausea, and/or vomiting
  • You have had a small bowel blockage in the last year, have a narrowing in your intestine, or have been diagnosed with or suspected to have a condition called gastroparesis (slow stomach emptying)
  • You are unable to give your own informed consent to participate
  • You are currently pregnant
  • You are currently incarcerated

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 16 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Oriana Damas, MD, University of Miami

Phone: 305-243-2515

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 4
Registry
ClinicalTrials.gov
Start date
5 March 2025
Est. completion
5 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in percentage of participants retained; Number of patients who adhere to diet measured by 24 hour dietary recall; Number of patients who adhere to medications measured by self report

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: 16 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