Phase 1 Crohn's Disease and Colitis Trial, Recruiting NCT05786404 Sponsor: The University of Texas Health Science Center, Houston Condition: Crohn's Disease and Colitis
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Phase 1 Crohn's Disease and Colitis Trial, Recruiting

NCT05786404
Recruiting Phase 1

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 have been diagnosed with active ulcerative colitis (UC) that is currently causing symptoms at a moderate level or above, based on a standard scoring system used by doctors.
  • If you are sexually active and could potentially father or carry a child, you must agree to use an effective form of birth control throughout the study.
  • If you are a woman who could become pregnant, you must have a negative pregnancy test at the start of the study and again before your first treatment dose.
  • You are willing and able to sign a consent form and attend all required clinic visits, check-ins, and follow-up calls.
  • You have a regular doctor who will manage your general UC care outside of this trial.

Who may not be able to join:

  • Your ulcerative colitis is classified as severe based on a doctor's scoring tool (confirm with trial site).
  • You are unable to receive an enema that needs to be held in, or unable to swallow multiple capsules.
  • You are currently pregnant, breastfeeding, or planning to become pregnant during the study.
  • You have taken antibiotic tablets or injections (not creams or topical treatments) within the past 14 days before starting treatment.
  • You currently have an active HIV, Hepatitis B, or Hepatitis C infection.
  • You have had a recurring C. difficile (a type of gut bacterial infection) or have received a fecal microbiota transplant (FMT) in the past 6 months.
  • You have another active gut condition, such as irritable bowel syndrome, celiac disease, or certain bowel surgeries, among others (confirm full list with trial site).
  • You have a known history of bile acid diarrhea (a specific type of diarrhea caused by bile salts — confirm with trial site).
  • Your immune system is weakened, either due to a medical condition or because you are taking immune-suppressing medications above a certain dose (confirm with trial site).
  • You have or have had an active cancer and/or are currently undergoing chemotherapy, unless your cancer is minor and non-spreading, or you are on a maintenance chemotherapy plan.
  • You have taken part in another medical research study involving an experimental drug within the last 90 days.
  • You have a serious ongoing health condition that, in the study doctor's judgment, could interfere with your participation in the trial.
  • Your life expectancy is less than one year.
  • Your blood test shows a very low level of a type of infection-fighting white blood cell called neutrophils (confirm with trial site).
  • The study doctor believes, for any reason, that you should not participate.

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
Phase 1: approximately ~10% 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: Herbert L DuPont, MD, The University of Texas Health Science Center, Houston

Phone: 713 500 6687

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 1
Registry
ClinicalTrials.gov
Start date
15 December 2023
Est. completion
15 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Disease severity as assessed by the Partial Mayo Score (PMS) for Ulcerative Colitis (UC); Change in fecal microbiota diversity and genera as assessed by sequencing; Change in proportion of antibody-coated microbiota as assessed by the antibiotic susceptibility test; Safety as assessed by the adverse events; Safety as assessed by the adverse events

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