An interventional study of combination of diagnostic tests in Crohn Disease of Intestine, sponsored by Sheba Medical Center. Active, not recruiting at 1 site in Israel. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-07.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Other
Crohn's' disease (CD) is a lifelong-chronic inflammatory condition of the digestive tract. CD frequently manifests during the 2nd or 3rd decade; prolonged disease duration frequently results in major structural complications such as strictures and fistulae, leading to surgery for control of complications in at least 30% of the patients. The course of disease is extremely diverse, ranging from a very mild disease to a devastating and incapacitating course. The burden of inflammatory bowel disease is growing each disease, reaching 400 billion USD for lifetime in US. In Israel, there are currently over 50000 IBD patients, with one of the highest incidences in the word, multiple treatment modalities and medications are available for Crohn's disease, however the efficacy is limited and the costs- very high. Furthermore, long-term exposure to some of the therapeutic agents poses an increased risk of infections and cancer.
Some of the major challenges in IBD include prediction of disease course (some patients will require early and aggressive treatment while others may just need observation and follow-up), and treatment personalization (right drug for the right patient at the right time). Unfortunately, individualized predictors of disease course and response to treatment are currently very limited. Some clues can be derived from imaging and endoscopy data, transcriptomics, genomic and microbiome, however those are still very premature and impractical. Moreover, large-scale studies with sophisticated predictive models that incorporate multilayered and multilayered clinical and omic data are severely lacking.
Goal:
Create comprehensive patient-multiomic profile (PRO-Visualosome-microbiome-transcriptome-pharmacokineticome) to develop algorithm-based personalized IBD therapy
Design Prospective observational cohort study.
Study aim To detect predictors of response to biologics using a layered multiomic approach
Cohort size Up to 140 patients in 2 years
Study duration -Patients will be followed up to 2 years (possible extension) or until treatment discontinuation or intestinal surgery
Study procedures All study procedures will be performed for the purpose of the study
Baseline
Disease activity using Harvey Bradshaw score at all timepoints and visits
First follow-up visit (12-14 weeks)
Every 3 months
Every 6 months
Upon failure (need to switch medication -defined by treating physician) or end of study
MRE
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's enrollment of 60 is close to the median of 66 across 1,188 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
capsule endoscopy, MRE , intestinal ultrasound, fecal microbiota, blood and serum biomarkers as described
failure of first biologic
cessation or switch of first biologic as per decision of the treating physician (documentation of change of therapy from the first biologic for any reason)
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center