Crohn DiseaseNCT06494826
Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
An observational study of Crohn Disease, run by Weizmann Institute of Science at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- colonoscopy procedure
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 May 2024to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CD study group will consist of candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD. Naïve to any medical or nutritional intervention. for 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.
Who may be able to join
- 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 join
- 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.
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- 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).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg - Eppendorf
Hamburg
Samuel Huber, Prof
Israel1 site, 1 recruiting
- Recruiting
Emek medical center
Afula
Eran Zeitan, Dr, eranzittan@clalit.org.il
About this study
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.
Read the 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 second visit of the study will occur 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
- Being tested
- colonoscopy procedure
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopy procedureOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| crohn disease patients | Candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD. Receives: Other: 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 Receives: Other: colonoscopy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of gut microbiota and associated molecules in Crohn's disease and healthy human gastrointestinal tract
Identification of changes in fecal microbiota and associated molecules using multi-dimensional analysis of fecal samples, biopsies and brushes collected during endoscopy
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 May 2024
- Primary completionMay 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weizmann Institute of Science
- Sponsor type
- University, hospital or other
- Collaborators
- HaEmek Medical Center, Israel, University of Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Eran Elinav, Prof, Principal investigator, Weizmann institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494826
- Sponsor's protocol ID
- 0078-23-EMC
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding the Clinical Impact of Host and Microbial Intestinal Proteomic Landscape in Crohn's Disease
- ClinicalTrials.gov ID
- NCT06494826
- Acronym / sponsor ID
- 0078-23-EMC
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Weizmann Institute of ScienceUniversity, hospital or other
- Collaborators
- HaEmek Medical Center, Israel, University of Hamburg-Eppendorf
- Study start
- 1 May 2024 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 second visit of the study will occur 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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crohn disease patients | – | Other: colonoscopy procedureCandidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD. |
| healthy controls | – | Other: colonoscopy procedurehealthy 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CD study group will consist of candidates for a medically-indicated, diagnostic colonoscopy due to suspected new-onset CD. Naïve to any medical or nutritional intervention. for 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopy procedureCandidates 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 . | Other | crohn disease patients, healthy controls |
Primary outcome
Characterization of gut microbiota and associated molecules in Crohn's disease and healthy human gastrointestinal tract
Time frame: 1 week
Identification of changes in fecal microbiota and associated molecules using multi-dimensional analysis of fecal samples, biopsies and brushes collected during endoscopy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eran Elinav, Prof principal investigator
Weizmann institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Weizmann Institute of Science at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eran Elinav, Prof (+97289524014, Eran.Elinav@weizmann.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of gut microbiota and associated molecules in Crohn's disease and healthy human gastrointestinal tract (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.