Capsule & Omics for pRedicting Exacerbation of Crohn's Disease

NCT ID: NCT06362174

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 62 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-07
• Study Completion Date: 2025-12-31

Brief 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 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.

Conditions

Crohn's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Prof. Shomron BenHorin

Director of the Institute for Gastrointestinal Diseases (Gastrology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shomron Ben- Horin, PhD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

Other Identifiers

SHEBA-22-9902-SBH-CTIL

Identifier Type: -

Identifier Source: org_study_id