Crohns DiseaseNCT06670638
Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy
An observational study of Crohns Disease, run by Alimentiv Inc. at 5 sites in 2 countries.
Trial summary
To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments. To allow this patient population to be included in clinical trials, outcome and measurement tools are needed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohns Disease
- How many people
- 50 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 19 Jun 2024to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Approximately 50 participants who meet the inclusion and exclusion criteria will be enrolled in the study. The study population will ideally include approximately equal distributions of participants with disease activity categorized by a central reader as normal, mild, moderate, and severe, according to the VAS assessment. It is not possible to predetermine the number of participants with specific disease activity levels. The distribution of inflammatory disease activity across the study population will be monitored on an ongoing basis and recruitment strategies may be reviewed for opportunities to help maintain a balanced distribution. No more than 10 asymptomatic participants will be enrolled.
Who may be able to join
- Adults (age ≥ 18 years) with a diagnosis of CD treated surgically with subtotal colectomy/proctocolectomy end ileostomy at least 12 months prior to the scheduled endoscopy procedure.
- Planning to have an ileoscopy procedure scheduled as part of routine medical care.
- Be proficient in the English language (ie, ability to read, write, speak, and understand English well enough to take part in the interview process without the aid of an interpreter).
- Able and willing to participate fully in all aspects of this study.
- Written informed consent must be obtained and documented.
Who cannot join
- End or loop colostomy, end ileostomy for UC, continent ileostomy, ileal pouch anal anastomosis, end ileostomy with mucous fistula, double barrel ileostomy, urostomy, loop ostomy, or any type of end ileostomy not considered permanent at the time of enrolment (with no intent to restore continuity).
- Peristomal skin complications such as pyoderma gangrenosum, abscess, or any other severe peristomal skin inflammation.
- Stomal stenosis obviating ileoscopy, known small bowel stricture, major stoma prolapse, symptomatic parastomal hernia, parastomal hernia with subcutaneous loops of small bowel within the hernia, stoma in a crease/poorly fitting applicable resulting in severe peristomal skin irritation, or retracted stoma that prevents endoscopic evaluation.
- Any actively draining fistula (eg, peristomal or peri-anal).
- Evidence of a known small bowel stricture on cross-sectional imaging or inability to pass an endoscope within the past 6 months.
- Known active Clostridoides difficile or other enteric infection.
Show all 10Show fewer
- Short bowel syndrome.
- Predominant symptom(s) arising from a retained rectal stump.
- Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study procedures or provide nonconfounded descriptions of their CD and ostomy symptom experiences during the interview.
- Prior enrolment in the current study.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Catherine Larson, larsenc@ccf.org
Florian Rieder
- Recruiting
Mayo Clinic- Rochester
Rochester, Minnesota, 55905
Brian Will, will.brian@mayo.edu
David Bruning
- Recruiting
Washington University in St Louis School of Medicine
St Louis, Missouri, 63110
Lulu Huang, luluhuang@wustl.edu
Parakkal Deepak
Canada2 sites, 2 recruiting
- Recruiting
McMaster University Medical Centre
Hamilton, Ontario, L6S 0E2
Jaimin Patel, patej102@mcmaster.ca
Neeraj Narula
- Recruiting
LHSC - University Campus
London, Ontario, L6S 0E2
Taylor Toth, taylor.toth@lhsc.on.ca
Vipul Jairath
About this study
To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments. To allow this patient population to be included in clinical trials, outcome and measurement tools are needed. This study aims to develop a Patient Reported Outcome (PRO) and Endoscopic Index (EI) for patients with Crohn's Disease (CD) and permanent ileostomy. The study will enroll about 50 participants and collect videos of endoscopies that are done as part of standard of care. The videos will be centrally read to identify features that represent a broad range of inflammation and will be used to develop the EI. Participants will also be asked to participate in interviews, to understand the symptoms and impacts that are most important to participants for the development of a PRO.
- Conditions
- Crohns Disease
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop a PRO instrument for patients with Crohn's Disease and Permanent Ileostomy
Concept elicitation interviews focusing on the symptoms and impacts relevant to patients with CD and permanent ileostomy will be conducted and used to develop a PRO. Cognitive interviews will subsequently be conducted to determine respondent comprehension and relevance of the items.
Measured: through study completion, and average of 1 year
Evaluate the intrarater reliability of 100-mm VAS.
Central readers will score endoscopy videos using the VAS, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Measured: At baseline and 2 weeks
Evaluate the intrarater reliability of RAM identified items.
Central readers will score endoscopy videos for items identified during a RAND/UCLA appropriateness method, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Measured: At baseline and 2 weeks
Evaluate the intrarater reliability of Rutgeerts score and its component items.
Central readers will score endoscopy videos using the Rutgeerts Score, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Measured: At baseline and 2 weeks
Evaluate the intrarater reliability of CDEIS and its component items.
Central readers will score endoscopy videos using the CDEIS, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Measured: At baseline and 2 weeks
Evaluate the intrarater reliability of SES-CD and its component items.
Central readers will score endoscopy videos using the SES-CD, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Measured: At baseline and 2 weeks
Evaluate the interrater reliability of 100-mm VAS.
Central readers will score endoscopy videos using the VAS, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Measured: At baseline
Evaluate the interrater reliability of RAM identified items.
Central readers will score endoscopy videos for items identified during a RAND/UCLA appropriateness method, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Measured: At baseline
Evaluate the interrater reliability of Rutgeerts score and its component items.
Central readers will score endoscopy videos using the Rutgeerts score, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Measured: At baseline
Evaluate the interrater reliability of CDEIS and its component items.
Central readers will score endoscopy videos using the CDEIS, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Measured: At baseline
Evaluate the interrater reliability of SES-CD and its component items.
Central readers will score endoscopy videos using the SES-CD, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Measured: At baseline
Develop a novel index using a multiple regression approach with the dependent variables being the VAS and candidate independent variables including items having at least moderate interrater reliability.
A prototype index will be created using the VAS for global assessment of severity as the dependent criterion. Prospective validation of the endoscopic index will be performed in a future initiative outside of the scope of this study.
Measured: through study completion, and average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start19 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohns DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alimentiv Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Western Ontario, Canada, The Leona M. and Harry B. Helmsley Charitable Trust, The Cleveland Clinic, OPEN Health (Pharmerit)
- Responsible party
- Sponsor
- Investigators
- Florian Rieder, Principal investigator, The Cleveland ClinicVipul Jairath, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670638
- Sponsor's protocol ID
- HEL01847
- Status last verified
- Nov 2025
- First submitted
- 30 Oct 2024
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Endoscopic Index and Patient-reported Outcome Measure for Clinical Trials in Participants With Permanent Ileostomy
- ClinicalTrials.gov ID
- NCT06670638
- Acronym / sponsor ID
- HEL01847
- Conditions
- Crohns Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alimentiv Inc.University, hospital or other
- Collaborators
- University of Western Ontario, Canada, The Leona M. and Harry B. Helmsley Charitable Trust, The Cleveland Clinic, OPEN Health (Pharmerit)
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To date, patients with Crohn's Disease (CD) and permanent ileostomies have been excluded from clinical trials for new treatments. To allow this patient population to be included in clinical trials, outcome and measurement tools are needed. This study aims to develop a Patient Reported Outcome (PRO) and Endoscopic Index (EI) for patients with Crohn's Disease (CD) and permanent ileostomy. The study will enroll about 50 participants and collect videos of endoscopies that are done as part of standard of care. The videos will be centrally read to identify features that represent a broad range of inflammation and will be used to develop the EI. Participants will also be asked to participate in interviews, to understand the symptoms and impacts that are most important to participants for the development of a PRO.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 50 participants who meet the inclusion and exclusion criteria will be enrolled in the study. The study population will ideally include approximately equal distributions of participants with disease activity categorized by a central reader as normal, mild, moderate, and severe, according to the VAS assessment. It is not possible to predetermine the number of participants with specific disease activity levels. The distribution of inflammatory disease activity across the study population will be monitored on an ongoing basis and recruitment strategies may be reviewed for opportunities to help maintain a balanced distribution. No more than 10 asymptomatic participants will be enrolled.
Key inclusion criteria (5 listed)
- Adults (age ≥ 18 years) with a diagnosis of CD treated surgically with subtotal colectomy/proctocolectomy end ileostomy at least 12 months prior to the scheduled endoscopy procedure.
- Planning to have an ileoscopy procedure scheduled as part of routine medical care.
- Be proficient in the English language (ie, ability to read, write, speak, and understand English well enough to take part in the interview process without the aid of an interpreter).
- Able and willing to participate fully in all aspects of this study.
- Written informed consent must be obtained and documented.
Key exclusion criteria (10 listed)
- End or loop colostomy, end ileostomy for UC, continent ileostomy, ileal pouch anal anastomosis, end ileostomy with mucous fistula, double barrel ileostomy, urostomy, loop ostomy, or any type of end ileostomy not considered permanent at the time of enrolment (with no intent to restore continuity).
- Peristomal skin complications such as pyoderma gangrenosum, abscess, or any other severe peristomal skin inflammation.
- Stomal stenosis obviating ileoscopy, known small bowel stricture, major stoma prolapse, symptomatic parastomal hernia, parastomal hernia with subcutaneous loops of small bowel within the hernia, stoma in a crease/poorly fitting applicable resulting in severe peristomal skin irritation, or retracted stoma that prevents endoscopic evaluation.
- Any actively draining fistula (eg, peristomal or peri-anal).
- Evidence of a known small bowel stricture on cross-sectional imaging or inability to pass an endoscope within the past 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop a PRO instrument for patients with Crohn's Disease and Permanent Ileostomy
Time frame: through study completion, and average of 1 year
Concept elicitation interviews focusing on the symptoms and impacts relevant to patients with CD and permanent ileostomy will be conducted and used to develop a PRO. Cognitive interviews will subsequently be conducted to determine respondent comprehension and relevance of the items.
Evaluate the intrarater reliability of 100-mm VAS.
Time frame: At baseline and 2 weeks
Central readers will score endoscopy videos using the VAS, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Evaluate the intrarater reliability of RAM identified items.
Time frame: At baseline and 2 weeks
Central readers will score endoscopy videos for items identified during a RAND/UCLA appropriateness method, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Evaluate the intrarater reliability of Rutgeerts score and its component items.
Time frame: At baseline and 2 weeks
Central readers will score endoscopy videos using the Rutgeerts Score, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Evaluate the intrarater reliability of CDEIS and its component items.
Time frame: At baseline and 2 weeks
Central readers will score endoscopy videos using the CDEIS, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Evaluate the intrarater reliability of SES-CD and its component items.
Time frame: At baseline and 2 weeks
Central readers will score endoscopy videos using the SES-CD, on 2 separate occasions at least 2 weeks apart. Intrarater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Evaluate the interrater reliability of 100-mm VAS.
Time frame: At baseline
Central readers will score endoscopy videos using the VAS, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Evaluate the interrater reliability of RAM identified items.
Time frame: At baseline
Central readers will score endoscopy videos for items identified during a RAND/UCLA appropriateness method, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Evaluate the interrater reliability of Rutgeerts score and its component items.
Time frame: At baseline
Central readers will score endoscopy videos using the Rutgeerts score, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Evaluate the interrater reliability of CDEIS and its component items.
Time frame: At baseline
Central readers will score endoscopy videos using the CDEIS, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Evaluate the interrater reliability of SES-CD and its component items.
Time frame: At baseline
Central readers will score endoscopy videos using the SES-CD, on 2 separate occasions at least 2 weeks apart. Interrater reliability will be quantified using ICC, which are equivalent to weighted Kappa statistics in the case of ordinal data.
Develop a novel index using a multiple regression approach with the dependent variables being the VAS and candidate independent variables including items having at least moderate interrater reliability.
Time frame: through study completion, and average of 1 year
A prototype index will be created using the VAS for global assessment of severity as the dependent criterion. Prospective validation of the endoscopic index will be performed in a future initiative outside of the scope of this study.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florian Rieder principal investigator
The Cleveland Clinic
Vipul Jairath principal investigator
Western University, Canada
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohns Disease, run by Alimentiv Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Olteanu (416-704-7734, ana.olteanu@alimentiv.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop a PRO instrument for patients with Crohn's Disease and Permanent Ileostomy (time frame: through study completion, and average of 1 year). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.