Studies protein changes in the gut of people with Crohn's disease
Examines gut proteins and microbes in adults with Crohn's disease, using colonoscopy samples.
Key facts
- Who runs it
- Weizmann Institute of Science
- Where
- Hamburg, GermanySee the siteAlso in 1 other country, 1 site
- Trial code
- Registry title
- Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
- Status
- Recruiting
- People taking part
- 40 people, planned
- Started
- 1 May 2024
- Expected to end
- May 2029
- Type of study
- Observational, 2 groups
- Treatments tested
- colonoscopy procedure
- Record updated
- 15 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with suspected new Crohn's disease who are due a colonoscopy and have had no treatment yet, plus a comparison group without Crohn's disease.
- Age
- 18 years or older.
- Sex
- All sexes can join.
- Disease stage
- Suspected new-onset Crohn's disease, with no extensive disease, no significant perianal disease, and no significantly stricturing or penetrating disease at presentation.
- Earlier treatment
- Must not have had any medical or nutritional treatment for Crohn's disease. No systemic antibiotics, probiotics or steroids in the 2 months before joining.
Main reasons for not taking part
- Already diagnosed inflammatory bowel disease that was treated before
- Type 1 or type 2 diabetes, or a past or present cancer
- BMI above 30
- Any previous major stomach or bowel surgery
- Pregnant or breastfeeding in the last 6 months
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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)
- BMI > 30 (kg/m2)
- Primary immunodeficiency
- Pregnancy or breastfeeding in the last 6 months
Where in Germany
Also in 1 other country, 1 site
- University Medical Center Hamburg-EppendorfHamburg, GermanyContact: Samuel Huber, ProfTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- crohn disease patients
Candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD.
Treatment: 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
Treatment: colonoscopy procedure
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
- Plain-language title
- Studies protein changes in the gut of people with Crohn's diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 15 September 2026