Crohn's Disease (CD)NCT06895772
Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With CD
An observational study of Crohn's Disease (CD), run by Shandong University at 1 site in China.
Trial summary
The characteristics of the intestinal microbiota in Crohn's disease and their relationship with disease pathogenesis have not yet been fully elucidated. Therefore, this study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of Crohn's disease patients and fill this knowledge… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn's Disease (CD)
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2024to 31 Dec 2025
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CD patients or healthy individuals
Who may be able to join
- Patients with Crohn's disease undergoing endoscopic examination
- Healthy individuals with no symptoms undergoing colonoscopy without any lesions detected
- Patients undergoing small intestinal endoscopy due to symptoms but with negative examination results.
- Age between 18 and 80 years.
- Patients or authorized family members sign the relevant informed consent forms.
Who cannot join
- Patients with concurrent digestive system diseases that may affect the study results, including tumors, infections, or other autoimmune diseases.
- Patients with concurrent non-digestive system diseases that may affect the study results, including tumors, infections, or autoimmune diseases.
- Patients who have taken probiotics or antibiotics within the past week.
- Patients with psychiatric disorders or other conditions that prevent them from cooperating with the study.
- Patients participating in other clinical trials that may interfere with the results of this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With Crohn's Disease
The characteristics of the intestinal microbiota in Crohn's disease and their relationship with disease pathogenesis have not yet been fully elucidated. Therefore, this study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of Crohn's disease patients and fill this knowledge gap. Additionally, this research holds significant importance for understanding the etiology of Crohn's disease and predicting treatment outcomes.
- Conditions
- Crohn's Disease (CD)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CD patients | Before receiving treatment, 2-4 biopsy samples of small or large intestinal mucosa are collected from Crohn's disease patients, including both lesional and normal tissues. During follow-up endoscopy performed 3-12 months after treatment for Crohn's disease patients, either due to symptoms or routine re-examination, 2-4 pieces of small or large intestinal mucosa are collected, including both lesional and normal tissues. Place the samples in a -80°C freezer for storage and submit them for 5R 16S high-throughput sequencing. | |
| Healthy individuals | Collect 1-2 pieces of large or small intestinal mucosa from healthy individuals with no symptoms who undergo colonoscopy and show no lesions, or from patients who undergo small intestinal endoscopy due to symptoms but have negative examination results. Place the samples in a -80°C freezer for storage and submit them for 5R 16S high-throughput sequencing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The characteristics of the intestinal microbiota in Crohn's disease
Analyze the characteristics of the microbiota within the intestinal mucosal tissue of patients with Crohn's disease；Analyze the differences in the microbiota between the lesional and normal intestinal mucosal tissues of patients with Crohn's disease；Analyze the differences in the microbiota within the intestinal mucosal tissue of patients with Crohn's disease before and after treatment.
Measured: 12 months
Secondary outcomes (1)
Contrast the characteristics of the intestinal microbiota in Crohn's disease and healthy individuals
Compare the differences in the microbiota within the intestinal mucosal tissue between patients with Crohn's disease and healthy individuals
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 Nov 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease (CD)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Qilu Hospital of Shandong University
- Investigators
- Xiuli Zuo, doctor, Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895772
- Sponsor's protocol ID
- 2025-SDU-Qilu-01
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT06895772
- Acronym / sponsor ID
- 2025-SDU-Qilu-01
- Conditions
- Crohn's Disease (CD)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 Mar 2025 (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.
The characteristics of the intestinal microbiota in Crohn's disease and their relationship with disease pathogenesis have not yet been fully elucidated. Therefore, this study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of Crohn's disease patients and fill this knowledge gap. Additionally, this research holds significant importance for understanding the etiology of Crohn's disease and predicting treatment outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CD patients | – | –Before receiving treatment, 2-4 biopsy samples of small or large intestinal mucosa are collected from Crohn's disease patients, including both lesional and normal tissues. During follow-up endoscopy performed 3-12 months after treatment for Crohn's disease patients, either due to symptoms or routine re-examination, 2-4 pieces of small or large intestinal mucosa are collected, including both lesional and normal tissues. Place the samples in a -80°C freezer for storage and submit them for 5R 16S high-throughput sequencing. |
| Healthy individuals | – | –Collect 1-2 pieces of large or small intestinal mucosa from healthy individuals with no symptoms who undergo colonoscopy and show no lesions, or from patients who undergo small intestinal endoscopy due to symptoms but have negative examination results. Place the samples in a -80°C freezer for storage and submit them for 5R 16S high-throughput sequencing. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CD patients or healthy individuals
Key inclusion criteria (5 listed)
- Patients with Crohn's disease undergoing endoscopic examination
- Healthy individuals with no symptoms undergoing colonoscopy without any lesions detected
- Patients undergoing small intestinal endoscopy due to symptoms but with negative examination results.
- Age between 18 and 80 years.
- Patients or authorized family members sign the relevant informed consent forms.
Key exclusion criteria (5 listed)
- Patients with concurrent digestive system diseases that may affect the study results, including tumors, infections, or other autoimmune diseases.
- Patients with concurrent non-digestive system diseases that may affect the study results, including tumors, infections, or autoimmune diseases.
- Patients who have taken probiotics or antibiotics within the past week.
- Patients with psychiatric disorders or other conditions that prevent them from cooperating with the study.
- Patients participating in other clinical trials that may interfere with the results of this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The characteristics of the intestinal microbiota in Crohn's disease
Time frame: 12 months
Analyze the characteristics of the microbiota within the intestinal mucosal tissue of patients with Crohn's disease；Analyze the differences in the microbiota between the lesional and normal intestinal mucosal tissues of patients with Crohn's disease；Analyze the differences in the microbiota within the intestinal mucosal tissue of patients with Crohn's disease before and after treatment.
1 secondary outcome
Contrast the characteristics of the intestinal microbiota in Crohn's disease and healthy individuals
Time frame: 12 months
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 26 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Xiuli Zuo, doctor study director
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease (CD), run by Shandong University at 1 site in China.
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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The characteristics of the intestinal microbiota in Crohn's disease (time frame: 12 months). 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 26 Mar 2025.