Crohn's Disease and Colitis Trial, Recruiting NCT05849012 Sponsor: University of Michigan Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT05849012
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 previously been diagnosed with Crohn's disease, confirmed through camera examination of the bowel, imaging scans, and/or tissue samples.
  • People whose Crohn's disease is currently in a quiet/inactive phase, shown by a stool test result below a certain level and/or no signs of inflammation seen on a colonoscopy done within a specific timeframe before joining.
  • People who still have ongoing symptoms such as stomach pain and/or diarrhoea that score at or above a certain level on a standardised symptom questionnaire developed by the National Institutes of Health.

Who may not be able to join:

  • People who have had their entire large bowel (colon) surgically removed.
  • People who currently have a stoma bag (ileostomy or colostomy) attached to their abdomen.
  • People who have changed their immune-suppressing medications in the past 4 weeks.
  • People who have taken antibiotics or probiotic supplements in the past 4 weeks.
  • People who have, or are suspected to have, a narrowing or blockage anywhere in their digestive tract.
  • People who normally follow a vegetarian or vegan diet.
  • People who are unwilling or unable to follow a low-sulphur diet during the trial.
  • People who are underweight (as measured by a body mass index below 18.5) or who have lost more than 7.5% of their body weight without trying over the past 3 months.
  • People who are currently pregnant or breastfeeding, or who are unwilling or unable to use contraception from the start of the study until after the final test is completed (confirm with trial site for full details on contraception requirements for both male and female participants).
  • People who are unwilling to avoid donating sperm, eggs, or breast milk from the start of the study until after the final test is completed.

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 16 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: Allen Lee, MD, MS, Assistant Professor

Phone: 734-936-9454

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
12 December 2023
Est. completion
30 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Dietary Protein Intake for both groups as assessed by 24 hour diet recall; Dietary Protein Intake as assessed by 24 hour diet recall; Change in 24 hour urinary sulfate; Change in 24 hour urinary sulfate

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: 16 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