Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
Recruiting · NCT06494826 · Observational (researchers observe without assigning treatment) · Lead sponsor: Weizmann Institute of Science
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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).
Where it is running
2 locations listed.
- Emek medical center - Afula, Israel
- University Medical Center Hamburg - Eppendorf - Hamburg, Germany