Capsule & Omics for pRedicting Exacerbation of Crohn's Disease (CORE-CD)

April 8, 2024 updated by: Prof. Shomron BenHorin, Sheba Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel-Hashomer, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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).

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • Pregnancy
  • Alcohol / drug dependency
  • Use of NSAIDs (including aspirin) for more than 3 continuous days, or during the 4 weeks preceding baseline visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
During hospitalization or after evaluation of tests results every 3 months, assessed up to 36 months
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.
During hospitalization or after evaluation of tests results every 3 months, assessed up to 36 months.
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)
Every 3 months, assessed up to 36 months.
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.
Every 3 months, assessed up to 36 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The rate of clinical flare accompanied by objective signs of mucosal inflammation.
Time Frame: through study completion, an average of 2 years.
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.
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.
defined as the occurrence of any of the aforementioned objective signs of mucosal inflammation
through study completion, an average of 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheba Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shomron Ben- Horin, PhD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHEBA-22-9902-SBH-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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