Crohn's Disease and Colitis Trial, Not Yet Recruiting NCT07671872 Sponsor: University of Miami Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Not Yet Recruiting

NCT07671872
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People who have a confirmed diagnosis of Crohn's Disease recorded in their medical records.
  • People aged between 16 and 75 years old.
  • People with mild to moderately active Crohn's Disease, measured using a standard scoring tool called the Crohn's Disease Activity Index (CDAI), with a score between 150 and 250, AND with signs of active inflammation shown by either a stool test result, or imaging scans, or a camera examination of the bowel taken within 4 weeks before the study starts.
  • People who have been on stable medications for their Crohn's Disease for at least 3 months, or as otherwise specified if the medication is not listed (confirm with trial site).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have been diagnosed with Ulcerative Colitis (a different type of bowel disease).
  • People who have previously had a surgical procedure called a J pouch or a bowel diversion.
  • People who have been hospitalised for their bowel disease in the last 4 weeks.
  • People who have had a gut infection called Clostridium difficile, or any other intestinal infection, in the last 4 weeks.
  • People who have used probiotic supplements or products in the last 4 weeks.
  • People who are currently following a specific carbohydrate diet, Mediterranean diet, or anti-inflammatory diet.
  • People who have active cancer, or a condition that makes it difficult to follow a specific diet, such as heart failure or advanced kidney disease.
  • People who are pregnant, breastfeeding, or planning to become pregnant during the study period.
  • People who are receiving nutrition delivered directly into the bloodstream (called Total Parenteral Nutrition) at the time of screening or during the study.
  • People who have other serious or life-threatening health conditions.
  • People who are expected to need antibiotic treatment during the study period.
  • Adults who are not able to give their own consent to participate.
  • People younger than 16 or older than 75 years of age.
  • People who are currently incarcerated.
  • People whose Crohn's Disease involves complications such as bowel narrowing in the past 12 months, internal fistulas (abnormal tunnels inside the body), a draining fistula near the anal area, or a previous bowel resection (surgical removal of part of the bowel).
  • People who also have a diagnosis of Coeliac disease.

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 31 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 M Damas, MD, MSCTI, University of Miami

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
Not Yet Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
1 August 2026
Est. completion
1 August 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Participants Achieving Crohn's Disease Activity Index (CDAI) Clinical Response; Participants Achieving Fecal Calprotectin (FC) Reduction

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: 31 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