Crohn's Disease and Colitis Trial, Recruiting NCT04121806 Sponsor: Mount Sinai Hospital, Canada Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT04121806
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 aged between 18 and 75 years old at the time of joining
  • People who have a confirmed diagnosis of ulcerative colitis (UC), established through standard tests such as a scope procedure, imaging, or tissue sample analysis
  • People whose UC is currently active, based on a specific scoring system (called the Mayo score) showing a result of 2 or higher within the two months before joining
  • People whose UC has affected more than 10cm of the bowel at some point in their illness
  • People who have a raised level of a gut inflammation marker in their stool (called faecal calprotectin, above 250) or who have had an active scope result within the last 6 months
  • People who smoke, provided they do not change how often they smoke during the study
  • People on existing UC medications, provided those medications have not changed in the 4 weeks before the study starts and remain unchanged throughout the study

Who may not be able to join:

  • People whose inflammation is so severe that surgery or a significant change in treatment may be needed within 4 weeks of joining
  • People who are pregnant or currently breastfeeding
  • People who have an allergy or intolerance to key ingredients or a large number of components in the study diet
  • People who are currently using NSAIDs (a common type of pain or anti-inflammatory medication, such as ibuprofen)
  • People who have been diagnosed with a liver condition called Primary Sclerosing Cholangitis (PSC)
  • People who are currently using topical bowel treatments or suppositories
  • People who have used antibiotics within 4 weeks of joining, or who need to use them during the study
  • People who have had a confirmed bowel infection called Clostridioides difficile within the 3 months before joining
  • People who have a history of abnormal cell changes (dysplasia) or bowel cancer

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

Phone: 4165864800

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
Sponsor
Mount Sinai Hospital, Canada
Registry
ClinicalTrials.gov
Start date
1 March 2021
Est. completion
30 September 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Change in microbiome composition; Change in microbiome function

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