Crohn Disease
Conditions
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 expressed in the GI tract under specific CD-relevant clinical contexts. This would enable us to (a) identify new commensals contributing to features of CD spectrum and various sub-types; (b) uncover the mechanistic basis of dysbiosis in CD (c) utilize the pipeline to develop new theranostic for disease exacerbation, complication and treatment responses; and (d) potentially enable future exploitation of novel AMP combinations, and their respective antimicrobial capacity to counteract dysbiosis in CD. Uncovering the proteomic manifestations of perturbed host-microbiome communications in CD will eventually enable the development and validation of clinical non-invasive surrogate markers, mechanistically determine causative drivers of CD, and potentially facilitate the development of novel therapeutic interventions.
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, demographic, and lifestyle habits questionnaires, as well as a food frequency questionnaire (FFQ). Participants will receive a home stool kit and will be instructed on how to use it. They will also receive a kit and an explanation regarding preparation materials for the colonoscopy. Subjects will be asked to collect stool samples at home - prior to colonoscopy and if possible - after colonoscopy bowel prep. The second visit of the study will occur on the day of colonoscopy. Each patient will be clinically assessed by a gastroenterologist using the Crohn's Disease Activity Index (CDAI)30 and Harvey-Bradshaw Index (HBI); and collection of luminal, brush cytology, and mucosal samples from 4 different lower intestine regions
Interventions
Candidates for a medically-indicated colonoscopy due to suspected new-onset CD or non-specific GI complaints or routine screening for colorectal cancer as part of primary prevention. colonoscopy will not be done for research purposes only .
Sponsors
Weizmann Institute of Science
HaEmek Medical Center, Israel
University of Hamburg-Eppendorf
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterization of gut microbiota and associated molecules in Crohn's disease and healthy human gastrointestinal tract | 1 week | Identification of changes in fecal microbiota and associated molecules using multi-dimensional analysis of fecal samples, biopsies and brushes collected during endoscopy |
Countries
Germany, Israel
Contacts
CONTACTEran Elinav, Prof
CONTACTshimrit eliyahu miller
PRINCIPAL_INVESTIGATOREran Elinav, Prof
Weizmann institute
Outcome results
None listed