Exploring the role of proteins in Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• University Medical Center Hamburg - Eppendorf
  Hamburg, Germany Recruiting
• Emek medical center
  Afula, Israel Recruiting

Study contacts

• Principal investigator: Eran Elinav, Prof — Weizmann institute
• Study coordinator: Eran Elinav, Prof
• Email: Eran.Elinav@weizmann.ac.il
• Phone: +97289524014

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Laser-based sizing of GI lesions during endoscopies

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• Claudin-2 Immunostaining to Detect Active or Inactive Inflammation in IBD Biopsies

  This study tests whether staining for Claudin-2 in intestinal biopsy samples can help identify active vs. inactive inflammation in people with ulcerative colitis or Crohn's disease.

  Recruiting IRCCS Policlinico S. Donato · San Donato Milanese, Mi · NCT07710287

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.