Crohn's Disease and Colitis Trial, Recruiting NCT06670638 Sponsor: Alimentiv Inc. Condition: Crohn's Disease and Colitis
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Crohn's Disease and Colitis Trial, Recruiting

NCT06670638
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:

  • Adults aged 18 or older who have been diagnosed with Crohn's disease and had surgery to remove most or all of their large bowel, resulting in a permanent opening in the abdomen (called an end ileostomy), at least 12 months before the study's scheduled camera examination.
  • People who are already scheduled to have a camera examination of the small bowel through their stoma (called an ileoscopy) as part of their regular medical care.
  • People who can read, write, speak, and understand English well enough to take part in interviews without needing an interpreter.
  • People who are able and willing to take part in all parts of the study.
  • People who have provided written consent to participate.

Who may not be able to join:

  • People who have a different type of stoma or bowel connection, such as a colostomy, a urostomy, a loop ostomy, a continent ileostomy, an ileal pouch, a double barrel ileostomy, a mucous fistula, or any ileostomy that is not considered permanent.
  • People who have serious skin problems around their stoma, such as a severe skin condition called pyoderma gangrenosum, an abscess, or severe skin inflammation in that area.
  • People whose stoma or bowel has physical problems that would prevent the camera examination from being done safely, such as a narrowed stoma, a significant bowel narrowing, a major stoma prolapse, a hernia near the stoma causing problems, a poorly positioned stoma causing severe skin irritation, or a stoma that sits too deep in the skin.
  • People who have any actively draining fistula (an abnormal opening leaking fluid) near the stoma or in the anal area.
  • People who have a known narrowing of the small bowel shown on recent scans, or where a camera scope could not be passed through in the past 6 months.
  • People with a known active bowel infection, such as a Clostridioides difficile infection or another gut infection.
  • People with short bowel syndrome (a condition where not enough of the small bowel remains to absorb nutrients properly).
  • People whose main symptoms are coming from a small piece of bowel left behind after surgery (called a retained rectal stump).
  • People with a serious health condition other than Crohn's disease that, in the study doctor's opinion, might affect their ability to fully participate or give clear descriptions of their symptoms.
  • People who have already taken part in this study before.

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 28 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: Florian Rieder, The Cleveland Clinic

Phone: 416-704-7734

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
Alimentiv Inc.
Registry
ClinicalTrials.gov
Start date
19 June 2024
Est. completion
30 June 2026

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Develop a PRO instrument for patients with Crohn's Disease and Permanent Ileostomy; Evaluate the intrarater reliability of 100-mm VAS.; Evaluate the intrarater reliability of RAM identified items.; Evaluate the intrarater reliability of Rutgeerts score and its component items.; Evaluate the intrarater reliability of CDEIS and its component items.; Evaluate the intrarater reliability of SES-CD and its component items.; Evaluate the interrater reliability of 100-mm VAS.; Evaluate the interrater reliability of RAM identified items.; Evaluate the interrater reliability of Rutgeerts score and its c...

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: 28 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