Crohn'sRecruiting
Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
Observational · No treatment assigned · 2 sites · Weizmann Institute of Science
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- Age ≥ 18
- Candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD.
- Naïve to any medical or nutritional intervention.
Plus 1 more requirement(s). There are also 14 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2024-05-01.
- Main results expected around 2028-05 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Germany and Israel.
Main thing being measured
- Characterization of gut microbiota and associated molecules in Crohn's disease and healthy human gastrointestinal tract (1 week)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease |
| Lead sponsor | Weizmann Institute of Science |
| Collaborators | HaEmek Medical Center, Israel; University of Hamburg-Eppendorf |
| Enrollment | 40 (estimated) |
| Start date | 2024-05-01 |
| Primary completion (est.) | 2028-05 |
| First posted | 2024-07-10 |
| Last updated | 2026-09-15 |
| Official title | Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease |
| ClinicalTrials.gov ID | NCT06494826 |
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 .
Full eligibility criteria (from the record)
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).
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Hamburg - Eppendorf | Hamburg | Germany | Recruiting |
| Emek medical center | Afula | Israel | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.