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

NCT ID: NCT06494826

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-05-31

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 seconed visit of the study will occure 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

Conditions

Crohn Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

crohn disease patients

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

colonoscopy procedure

Intervention Type: 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 .

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

colonoscopy procedure

Intervention Type: 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 .

Interventions

colonoscopy procedure

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 .

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: collaborator

Weizmann Institute of Science

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Emek medical center

Afula, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Eran Elinav, Prof

Role: CONTACT

Eran.Elinav@weizmann.ac.il

+97289524014

shimrit eliyahu miller

Role: CONTACT

Shimrit.miller@weizmann.ac.il

+97289524014

Facility Contacts

Eran Zeitan, Dr

Role: primary

eranzittan@clalit.org.il

Other Identifiers

0078-23-EMC

Identifier Type: -

Identifier Source: org_study_id