NCT06494826Recruiting
Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 40 (estimated)
- First submitted
- 2 Jul 2024
- Start date
- 1 May 2024
- Primary completion date
- May 2028
- Lead sponsor
- Weizmann Institute of Science
- Diseases
- Crohn's disease
- NCT number
- NCT06494826
What you commit to
- Study type: Observational
- Planned participants: 40
- From 1 May 2024 to the primary completion date, May 2028
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Established diagnosis of inflammatory bowel disease (IBD) with prior treatment.
- 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.
- 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.
Other illness
- 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.
- Suspected or proven extensive involvement of non-ileal small intestine or colon, or significant perianal disease.
- Significantly stricturing or penetrating (fistulizing) disease at presentation.
- Serious medical conditions that may alter the gut microbiome composition, based on investigators judgement (for example primary immunodeficiency, autoimmune disorder, or rheumatologic disease).
Other
- BMI \> 30 (kg/m2)
- Primary immunodeficiency.
- Pregnancy or breastfeeding in the last 6 months.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Emek Medical Center Coordinator of this site? Confirm its status | Afula | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.