Crohn's Disease and Colitis Trial, Recruiting NCT04401605 Sponsor: Stanford University Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT04401605
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 are willing and able to provide written consent to take part
  • Men or women aged 18 or older
  • People who have a confirmed diagnosis of ulcerative colitis (UC)
  • People who are currently experiencing active symptoms, based on a specific disease activity score falling within a moderate range (partial Mayo Score of 2 to 7)
  • People who have an elevated level of a specific protein in their stool that indicates gut inflammation (called fecal calprotectin)

Who may not be able to join:

  • Women who are pregnant, currently breastfeeding, or planning to become pregnant
  • People who cannot tolerate fermented foods
  • People with a body mass index (BMI) below 18 (considered underweight)
  • People who have been diagnosed with a serious medical condition, unless a doctor has given written approval for participation
  • People who have been severely weakened or debilitated by a disease or medical procedure
  • People with more than mild-to-moderate heart or blood vessel disease, or a life-threatening cancer, unless a doctor has specifically approved their participation
  • People with a history of serious heart disease — particularly a type of heart failure that is not well controlled, or significantly reduced heart pumping function (confirm with trial site)
  • People who have had major bowel surgery in the past, such as removal of all or part of the colon, or a stoma procedure

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 9 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: Sidhartha Sinha, MD, Stanford University

Phone: 6507367311

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
14 September 2020
Est. completion
30 June 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in the clinical disease activity inflammatory marker fecal calprotectin

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: 9 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