Phase 2 Crohn's Disease and Colitis Trial, Recruiting NCT06351124 Sponsor: University of Texas at Austin Condition: Crohn's Disease and Colitis
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Phase 2 Crohn's Disease and Colitis Trial, Recruiting

NCT06351124
Recruiting Phase 2

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:

  • You are 18 years old or older
  • You have been diagnosed with Crohn's disease
  • Your Crohn's disease is currently active, shown either by a stool test result (calprotectin above 250 µg/g) or a camera test (endoscopy) in the last 3 months
  • You are about to start a new medication for Crohn's disease, either a biologic injection/infusion (such as an anti-TNF, anti-integrin, or IL-12/23 or IL-23 blocker) or a newer type of tablet (such as a JAK inhibitor or S1P receptor modulator)
  • You are willing to sign a consent form to take part in the study
  • You are a patient at the UT Digestive Health Clinic

Who may not be able to join:

  • You are currently taking or have taken a BHB (beta-hydroxybutyrate) supplement in the last 4 weeks
  • You are currently following or have recently followed a ketogenic (very low carbohydrate) diet in the last 4 weeks
  • You are currently following or have recently followed an intermittent fasting diet in the last 4 weeks
  • You have taken antibiotics in the last 3 months
  • You have had a C. difficile (a type of gut infection) in the last 6 months
  • You are currently taking or have recently taken daily acid-reducing medications (such as omeprazole or ranitidine) in the last 4 weeks
  • You are currently taking or have recently taken probiotic supplements (not food-based) in the last 4 weeks
  • You are not willing to sign a 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 23 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Linda A. Feagins, Associate Professor, MD, University of Texas at Austin

Phone: 512-495-5641

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
Phase 2
Sponsor
University of Texas at Austin
Registry
ClinicalTrials.gov
Start date
28 August 2024
Est. completion
1 April 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Ability to enroll patients who meet the inclusion criteria within the target time frame; Adherence to proposed study timelines and anticipated study costs; Patient adherence to the intervention

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: 23 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