Exploring the role of proteins in Crohn's Disease

Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease

This study is trying to see how proteins in the gut and the bacteria living there affect people with Crohn's Disease to find new ways to manage the condition.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Weizmann Institute of Science (Academic / other)
• Locations: 1 site (Afula)
• Trial ID: NCT06494826 on ClinicalTrials.gov

What this trial studies

This observational study investigates the protein-based interactions between the host and gut microbiome in patients with Crohn's Disease (CD). Participants will be recruited from outpatient clinics and will provide stool samples before and after a colonoscopy, during which clinical assessments will be conducted. The study aims to identify new microbial contributors to CD, understand the mechanisms of dysbiosis, and develop non-invasive markers for disease management. By analyzing the intestinal proteomic landscape, the research seeks to pave the way for novel therapeutic strategies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are undergoing a medically-indicated colonoscopy for suspected new-onset Crohn's Disease.

Not a fit: Patients with established inflammatory bowel disease or chronic gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic approaches for Crohn's Disease.

How similar studies have performed: While the approach of analyzing the intestinal proteomic landscape is innovative, similar studies have shown promise in understanding gut microbiome interactions in other gastrointestinal conditions.

Eligibility criteria

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 this trial is running

Afula

• Emek medical center — Afula, Israel (Recruiting)

Study contacts

• Study coordinator: Eran Elinav, Prof

Conditions Crohn Disease