Early Phase 1 Crohn's Disease and Colitis Trial, Recruiting NCT07170462 Sponsor: Ana Maldonado-Contreras Condition: Crohn's Disease and Colitis
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Early Phase 1 Crohn's Disease and Colitis Trial, Recruiting

NCT07170462
Recruiting Early 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 are between 18 and 65 years old and have been diagnosed with Crohn's disease.
  • Your Crohn's disease activity is at a moderate or lower level (based on a specific scoring system used by doctors — confirm with trial site).
  • Your quality of life is moderately to severely affected by your condition (based on a specific quality of life score — confirm with trial site).
  • If you are a woman who could become pregnant, you must be willing to use at least one highly effective form of birth control throughout the study.
  • You have been on a stable dose of any current medications for a set period of time before joining (the length of time varies by medication — confirm with trial site).
  • You are willing and able to take a cranberry supplement every day as required by the study.
  • You are willing to provide samples (such as stool or blood samples) and follow all other study procedures.
  • You are able to give written consent to participate.
  • You currently live in Massachusetts, USA.

Who may not be able to join:

  • You have an ostomy (a surgically created opening in the abdomen for waste removal).
  • You have a significant narrowing of the intestine or have had a bowel blockage in the past 6 months.
  • You are currently pregnant.
  • You have been following a Specific Carbohydrate Diet or IBD-AID diet within the past 4 weeks.
  • You have taken probiotics within the past 4 weeks.
  • You have taken antibiotics within the past 4 weeks.
  • You are taking more than 20mg of prednisone (or a similar steroid medication) per day.
  • You have recently had a C. difficile bowel infection (confirm with trial site for timeframe).
  • You are not able to give informed consent for yourself.
  • You are currently incarcerated.
  • You are under 18 years old.

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
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Ana Maldonado-Contreras, PhD, University of Massachusetts, Worcester

Phone: 508-856-5279

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
Early Phase 1
Sponsor
Ana Maldonado-Contreras
Registry
ClinicalTrials.gov
Start date
29 October 2025
Est. completion
15 August 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in relative abundance of butyrate-producing Clostridia species, assessed with shotgun metagenomic sequencing and MetaPhlAn taxonomic profiling

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