Crohn's Disease and Colitis Trial, Recruiting NCT06784323 Sponsor: University of Miami Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT06784323
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:

  • People who have a confirmed diagnosis of ulcerative colitis, documented in their medical records
  • People who identify as American
  • People between the ages of 16 and 75
  • People whose ulcerative colitis symptoms fall within a certain moderate range, including no more than 12 bowel movements per day (measured using a scoring tool called the SCCAI — confirm with trial site)
  • People whose stool test shows a fecal calprotectin level above 150mg/dl, which is a marker of gut inflammation
  • People who have been on a stable medication routine for their condition for at least the past 3 months
  • People who enjoy typical American foods such as sandwiches, BBQ or grilled meats and vegetables, baked potatoes, smoothies, salmon, oatmeal, avocado, and soups
  • People who have not been hospitalised for their bowel disease in the past month

Who may not be able to join:

  • People who have a diagnosis of Crohn's disease
  • People who have previously had a surgical procedure connecting the small intestine to the anus (sometimes called a J-pouch), or a bowel diversion surgery
  • People who have been hospitalised for any reason in the past 4 weeks
  • People who have had a Clostridioides difficile infection or any other gut infection in the past 4 weeks
  • People who have used probiotic supplements in the past 4 weeks
  • People who are already following a specific carbohydrate diet, Mediterranean diet, or anti-inflammatory diet
  • People who have active cancer, heart failure, or advanced kidney disease, or any condition that limits their ability to follow a specific diet
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study period
  • People who are receiving nutrition entirely through an intravenous line (called Total Parenteral Nutrition) at the time of screening or during the study
  • People with other serious or life-threatening health conditions
  • People who may need to take antibiotics during the study period
  • Adults who are not able to provide their own informed consent to participate
  • People under 16 or over 75 years of age
  • People who 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 28 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: Oriana Damas, MD, MSCTI, University of Miami Health System

Phone: 305 243-6405

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
5 March 2025
Est. completion
1 September 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Clinical response after diet intervention measured by simple clinical colitis activity index (SCCAI)

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