Crohn's Disease and Colitis Trial, Recruiting NCT05579392 Sponsor: Rush University Medical Center Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT05579392
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 Crohn's disease or Ulcerative Colitis, proven by a biopsy
  • People who are 18 years of age or older
  • People who have elevated levels of a gut inflammation marker (fecal calprotectin or CRP) on a blood or stool test, or who score 50 or above on a fatigue measurement scale called the PROMISE Fatigue scale
  • People who have been taking a stable dose of a biologic medication, an immunomodulator, or a 5-ASA medication for at least 12 weeks

Who may not be able to join:

  • People whose IBD is currently very active, based on specific symptom scoring tools used by doctors (confirm with trial site)
  • People with major depression, based on a score of 21 or higher, or any indication of suicidal thoughts, on the Beck Depression Inventory
  • People considered high risk for sleep apnea, based on scoring high risk in two or more categories of a questionnaire called the Berlin Questionnaire
  • People with restless leg syndrome, based on a score of 15 or higher on the IRLS Study Group Rating Scale
  • People who have regularly used certain medications in the four weeks before the study, including metoclopramide, anti-inflammatory pain relievers (NSAIDs), beta blockers, psychiatric medications, sleeping tablets, or melatonin supplements
  • People who have worked night shifts or travelled across more than two time zones in the month before the study
  • People with significant kidney, liver, heart, or diabetes-related conditions, based on specific test results reviewed by a doctor
  • People who have been diagnosed with narrow-angle glaucoma or retinal eye disorders, or who showed symptoms suggesting these conditions during screening
  • People who are unable to sign an informed consent form

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 7 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: Ali Keshavarzian, M.D., Rush University Medical Center

Phone: (312) 563-4981

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
Rush University Medical Center
Registry
ClinicalTrials.gov
Start date
22 September 2022
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Changes in intestinal permeability (% excretion of urinary sucralose); Changes in microbiota will be assessed using shotgun metagene sequencing and total microbial community DNA

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: 7 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