Crohn's DiseaseCORE-CDNCT06362174
Capsule & Omics for pRedicting Exacerbation of Crohn's Disease
An observational study of Crohn's Disease, run by Sheba Medical Center at 1 site in Israel.
Trial summary
The research group have previously evaluated the benefit of serial consecutive capsule endoscopy as monitoring tool for Crohn's disease in remission, demonstrating its superior accuracy for disclosing inflammation and for prediction of flares in comparison to other diagnostic modalities such as magnetic resonance… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Crohn's Disease
- How many people
- 62 participants
- Where
- 1 siteIsrael
- Study dates
- 7 Feb 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Eligible patients will consist of adult CD patients >16YO in clinical remission, as determined by the validated Crohn's disease activity index (CDAI) of <150 and whose disease is known to involve the small bowel as either small bowel CD or ileo-colonic CD. Patients will have to be in steroid-free remission, whether induced medically or surgically, for at least 3 months before inclusion. Patients will be included regardless of the medication used for their treatment, but the dose of medication will be required to be stable before enrollment (60 days for thiopurines, Methotrexate, infliximab, vedolizumab, adalimumab and ustekinumab, 30 days for all other agents).
Who may be able to join
- Age above 16
- Established Crohn's disease (CD) for at least 3 months
- Steroid free remission whether induced medically or surgically, for at least 3 months before inclusion
- CDAI<150
- Stable dose before enrollment:
- 60 days for thiopurines, Methotrexate, Infliximab and Vedolizumab; 30 days for all other agents.
Who cannot join
- Corticosteroid use within the last 3 months
- Severe co-morbidities: liver, kidney, neurologic, metabolic or cardio-respiratory disorders not controlled at the time of enrollment
- Difficulty swallowing / history of aspirations or dysphagia
- Implanted metal objects precluding performance of MRI
- Cardiac pace-maker
- Known or suspected intestinal obstruction/stricture
Show all 9Show fewer
- Pregnancy
- Alcohol / drug dependency
- Use of NSAIDs (including aspirin) for more than 3 continuous days, or during the 4 weeks preceding baseline visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Capsule & Omics for pRedicting Exacerbation of Crohn's Disease (CORE-CD)
The research group have previously evaluated the benefit of serial consecutive capsule endoscopy as monitoring tool for Crohn's disease in remission, demonstrating its superior accuracy for disclosing inflammation and for prediction of flares in comparison to other diagnostic modalities such as magnetic resonance enterography and inflammatory biomarkers. Subsequently, deep learning algorithms had developed to provide excellent accuracy for identification and grading of ulcers and intestinal strictures on capsule endoscopy still images. The investigators will advance this knowledge using a parallel two-parts approach.
Read the detailed description
Part I - A retrospective study will use stored capsule and clinical datasets from 120 previously enrolled CD patients in remission, who underwent capsule based 24-months monitoring as part of two prior similar research projects (60 in each of the Israeli Inflammatory bowel disease Research Nucleus (IIRN), IIRN-I and IIRN-II-CURE- projects), aiming to predict and prevent flares based on capsule studies. The investigators will now utilize the accumulated visual data to develop AI-based complete film readouts and integrate the resultant visual omics data with previously derived microbiome and biomarker data, to serve as a discovery cohort for machine learning models predicting clinical exacerbation in patients in remission, which was witnessed in 27% of IIRN-I cohort within the 24m study.
Part II - A prospective observational study will enroll a new IIRN-III cohort of 60 (+6 attrition-considered) Crohn's Disease patients>16 years old in clinical remission. The investigators will deliberately use similar inclusion, monitoring design and outcome definitions as IIRN-I \& II studies, to allow cross-cohort comparative validity. Procedures will include baseline colonoscopy, pan-enteric capsule and magnetic resonance enterography/Intestinal ultrasound, and thereafter serial capsule studies or every 6 months for 24 months. Newly acquired Omics will include baseline mucosal +colonic wash transcriptomics obtained during the baseline colonoscopy, serial dense stool microbiome and blood metabolomics, and a computerized frequency questionnaire, diet omics data. A densely sampled 24 months stool will be used to develop novel multi-omics tools predicting flares. The investigators will also use the datasets to explore the mechanisms and pathways involved in triggering remission transition into a clinical flare.
Follow- up can optionally extend to 36 months.
- Conditions
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Crohn's Disease Activity Index score (CDAI)
The rate of clinical relapse or disease complication by 24 months after inclusion defined as Crohn's Disease Activity Index above 150 and a rise above 70 points from pre flare value.
Patients who experience CDAI score worsening without any other objective signs of disease inflammatory flare (i.e. without elevated C reactive protein (CRP) levels or elevated calprotectin levels or abnormal video capsule endoscopy (VCE) score) and without complication or change of CD medications - will be considered as primary outcome as per the original protocol definitions, but may be maintained on the study follow-up plan for the intended follow up period of 24 months or until 36 months.
Measured: Score will be calculated every 3 months assessed up to 36 months. If score above 150 and a rise above 70 points from baseline patient will be withdrawn with clinical flare
Disease related complications
onset of obstructive symptoms coupled with objective imaging and/or endoscopic evidence of new intestinal stricture, or occurrence of new penetrating complication.
Measured: During hospitalization or after evaluation of tests results every 3 months, assessed up to 36 months
disease related hospitalization
Disease related hospitalization in which patient was hospitalized due to disease related complications or flare.
Measured: During hospitalization or after evaluation of tests results every 3 months, assessed up to 36 months.
Change of crohn's disease medications
change of crohn's disease medications (type or dose)
Measured: Every 3 months, assessed up to 36 months.
opinion of the principle investigator (PI) or the treating physician
Patients withdrawn due physician judgment of severity of mucosal lesions on video capsule endoscopy mandating change of therapy will be considered as non-responder (i.e. experienced a flare) for the purpose of the primary outcome.
Measured: Every 3 months, assessed up to 36 months.
Secondary outcomes (2)
The rate of clinical flare accompanied by objective signs of mucosal inflammation.
The later include Lewies score>350 + an increase of at least 225 Lewies score points from baseline on video capsule endoscopy study, OR a calprotectin above 250 with a at least 50% increase from baseline level, OR a C-Reactive Protein level more than X2 from upper limit of normal (ULN) for a patient with normal C-Reactive Protein at baseline.
Measured: through study completion, an average of 2 years.
The rate of inflammatory worsening with/without accompanying clinical symptoms
defined as the occurrence of any of the aforementioned objective signs of mucosal inflammation
Measured: through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start7 Feb 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Shomron BenHorin, Sheba Medical Center
- Investigators
- Shomron Ben- Horin, PhD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362174
- Sponsor's protocol ID
- SHEBA-22-9902-SBH-CTIL
- Acronym
- CORE-CD
- Status last verified
- Apr 2024
- First submitted
- 13 Feb 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsule & Omics for pRedicting Exacerbation of Crohn's Disease (CORE-CD)
- ClinicalTrials.gov ID
- NCT06362174
- Acronym / sponsor ID
- CORE-CD / SHEBA-22-9902-SBH-CTIL
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 Apr 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.
The research group have previously evaluated the benefit of serial consecutive capsule endoscopy as monitoring tool for Crohn's disease in remission, demonstrating its superior accuracy for disclosing inflammation and for prediction of flares in comparison to other diagnostic modalities such as magnetic resonance enterography and inflammatory biomarkers. Subsequently, deep learning algorithms had developed to provide excellent accuracy for identification and grading of ulcers and intestinal strictures on capsule endoscopy still images. The investigators will advance this knowledge using a parallel two-parts approach.
Detailed description
Part I - A retrospective study will use stored capsule and clinical datasets from 120 previously enrolled CD patients in remission, who underwent capsule based 24-months monitoring as part of two prior similar research projects (60 in each of the Israeli Inflammatory bowel disease Research Nucleus (IIRN), IIRN-I and IIRN-II-CURE- projects), aiming to predict and prevent flares based on capsule studies. The investigators will now utilize the accumulated visual data to develop AI-based complete film readouts and integrate the resultant visual omics data with previously derived microbiome and biomarker data, to serve as a discovery cohort for machine learning models predicting clinical exacerbation in patients in remission, which was witnessed in 27% of IIRN-I cohort within the 24m study.
Part II - A prospective observational study will enroll a new IIRN-III cohort of 60 (+6 attrition-considered) Crohn's Disease patients>16 years old in clinical remission. The investigators will deliberately use similar inclusion, monitoring design and outcome definitions as IIRN-I \& II studies, to allow cross-cohort comparative validity. Procedures will include baseline colonoscopy, pan-enteric capsule and magnetic resonance enterography/Intestinal ultrasound, and thereafter serial capsule studies or every 6 months for 24 months. Newly acquired Omics will include baseline mucosal +colonic wash transcriptomics obtained during the baseline colonoscopy, serial dense stool microbiome and blood metabolomics, and a computerized frequency questionnaire, diet omics data. A densely sampled 24 months stool will be used to develop novel multi-omics tools predicting flares. The investigators will also use the datasets to explore the mechanisms and pathways involved in triggering remission transition into a clinical flare.
Follow- up can optionally extend to 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Eligible patients will consist of adult CD patients >16YO in clinical remission, as determined by the validated Crohn's disease activity index (CDAI) of <150 and whose disease is known to involve the small bowel as either small bowel CD or ileo-colonic CD. Patients will have to be in steroid-free remission, whether induced medically or surgically, for at least 3 months before inclusion. Patients will be included regardless of the medication used for their treatment, but the dose of medication will be required to be stable before enrollment (60 days for thiopurines, Methotrexate, infliximab, vedolizumab, adalimumab and ustekinumab, 30 days for all other agents).
Key inclusion criteria (6 listed)
- Age above 16
- Established Crohn's disease (CD) for at least 3 months
- Steroid free remission whether induced medically or surgically, for at least 3 months before inclusion
- CDAI<150
- Stable dose before enrollment:
Key exclusion criteria (9 listed)
- Corticosteroid use within the last 3 months
- Severe co-morbidities: liver, kidney, neurologic, metabolic or cardio-respiratory disorders not controlled at the time of enrollment
- Difficulty swallowing / history of aspirations or dysphagia
- Implanted metal objects precluding performance of MRI
- Cardiac pace-maker
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
Crohn's Disease Activity Index score (CDAI)
Time frame: Score will be calculated every 3 months assessed up to 36 months. If score above 150 and a rise above 70 points from baseline patient will be withdrawn with clinical flare
The rate of clinical relapse or disease complication by 24 months after inclusion defined as Crohn's Disease Activity Index above 150 and a rise above 70 points from pre flare value. Patients who experience CDAI score worsening without any other objective signs of disease inflammatory flare (i.e. without elevated C reactive protein (CRP) levels or elevated calprotectin levels or abnormal video capsule endoscopy (VCE) score) and without complication or change of CD medications - will be considered as primary outcome as per the original protocol definitions, but may be maintained on the study follow-up plan for the intended follow up period of 24 months or until 36 months.
Disease related complications
Time frame: During hospitalization or after evaluation of tests results every 3 months, assessed up to 36 months
onset of obstructive symptoms coupled with objective imaging and/or endoscopic evidence of new intestinal stricture, or occurrence of new penetrating complication.
disease related hospitalization
Time frame: During hospitalization or after evaluation of tests results every 3 months, assessed up to 36 months.
Disease related hospitalization in which patient was hospitalized due to disease related complications or flare.
Change of crohn's disease medications
Time frame: Every 3 months, assessed up to 36 months.
change of crohn's disease medications (type or dose)
opinion of the principle investigator (PI) or the treating physician
Time frame: Every 3 months, assessed up to 36 months.
Patients withdrawn due physician judgment of severity of mucosal lesions on video capsule endoscopy mandating change of therapy will be considered as non-responder (i.e. experienced a flare) for the purpose of the primary outcome.
2 secondary outcomes
The rate of clinical flare accompanied by objective signs of mucosal inflammation.
Time frame: through study completion, an average of 2 years.
The rate of inflammatory worsening with/without accompanying clinical symptoms
Time frame: through study completion, an average of 2 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
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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. This study is not recruiting at the moment.
Shomron Ben- Horin, PhD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Sheba Medical Center at 1 site in Israel.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crohn's Disease Activity Index score (CDAI) (time frame: Score will be calculated every 3 months assessed up to 36 months. If score above 150 and a rise above 70 points from baseline patient will be withdrawn with clinical flare). The study lists 5 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 Apr 2024.