NCT06494826 Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
| NCT ID | NCT06494826 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weizmann Institute of Science |
| Condition | Crohn Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-05-01 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Eran Elinav, Prof
PRINCIPAL INVESTIGATOR
Weizmann institute
Frequently Asked Questions
Who can join the NCT06494826 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06494826 currently recruiting?
Yes, NCT06494826 is actively recruiting participants. Contact the research team at Eran.Elinav@weizmann.ac.il for enrollment information.
Where is the NCT06494826 trial being conducted?
This trial is being conducted at Hamburg, Germany, Afula, Israel.
Who is sponsoring the NCT06494826 clinical trial?
NCT06494826 is sponsored by Weizmann Institute of Science. The principal investigator is Eran Elinav, Prof at Weizmann institute. The trial plans to enroll 40 participants.