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

NCT06494826 | Recruiting

• 1 other identifier: 0078-23-EMC
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Characterization of gut microbiota and associated molecules in Crohn's disease and healthy human gastrointestinal tract

  Identification of changes in fecal microbiota and associated molecules using multi-dimensional analysis of fecal samples, biopsies and brushes collected during endoscopy

  1 week

Study Arms (2)

crohn disease patients

Candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD.

Other: colonoscopy procedure

healthy controls

healthy participants 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

Other: colonoscopy procedure

Interventions

colonoscopy procedure OTHER

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 .

crohn disease patients; healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CD study group will consist of candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD. Naïve to any medical or nutritional intervention. for 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.

You may qualify if:

• Age ≥ 18
• Candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD.
• Naïve to any medical or nutritional intervention.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Weizmann Institute of Science: lead
• HaEmek Medical Center, Israel: collaborator

Study Sites (1)

Emek medical center

Afula, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool samples blood samples gastrointestinal brushes gastrointestinal biopsies

MeSH Terms

Conditions

Crohn Disease

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Eran Elinav, Prof

CONTACT

+97289524014; Eran.Elinav@weizmann.ac.il

shimrit eliyahu miller

CONTACT

+97289524014; Shimrit.miller@weizmann.ac.il

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

IL (1)