Status:
RECRUITING
Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
Lead Sponsor:
Weizmann Institute of Science
Collaborating Sponsors:
HaEmek Medical Center, Israel
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Brief Summary
In this study, the investigators will explore our protein-based platform assessing commensals potentially contributing to features of CD, while assessing the global composition and abundance of AMPs e...
Detailed Description
Participants will be recruited from a community outpatient clinics and from a leading outpatient gastroenterology clinic: Emek Medical Center, after ICF signing , they will fill out a medical, demogra...
Eligibility Criteria
Inclusion
- Inclusion criteria - CD study group:
- Age ≥ 18
- Candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD.
- Naïve to any medical or nutritional intervention.
- Inclusion criteria - healthy controls:
- • Age- and gender-matched patients to the CD group, admitted for non-specific GI complaints (such as changes in bowel movements, bloating, abdominal pain) or routine screening for colorectal cancer as part of primary prevention per clinical guidelines.
- Exclusion Criteria - both groups:
- Established diagnosis of inflammatory bowel disease (IBD) with prior treatment.
- Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
- Type 1 or type 2 diabetes mellitus.
- Past or present history of malignancy.
- BMI \> 30 (kg/m2)
- Use of systemic antibiotics or probiotics 2 months prior to enrolment.
- Use of steroids 2 months prior to enrolment (not including a short course of topical steroidal therapy).
- Any previous major gastric or intestinal surgery.
- Suspected or proven extensive involvement of non-ileal small intestine or colon, or significant perianal disease.
- Significantly stricturing or penetrating (fistulizing) disease at presentation.
- Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalers/creams/ointments should not be excluded from the study.
- Primary immunodeficiency.
- Pregnancy or breastfeeding in the last 6 months.
- Serious medical conditions that may alter the gut microbiome composition, based on investigators judgement (for example primary immunodeficiency, autoimmune disorder, or rheumatologic disease).
Exclusion
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06494826
Start Date
May 1 2024
End Date
May 1 2027
Last Update
July 20 2025
Active Locations (1)
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1
Emek medical center
Afula, Israel