Behcet's Syndrome, Intestinal TypeNCT06026020
Pathogenesis of Intestinal Behcet's Syndrome
An observational study of Behcet's Syndrome, Intestinal Type, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
There is a direct interaction between food, intestinal flora and the intestinal barrier composed of intestinal epithelial cells and mucosal immunity, whose composition and functional alterations are theorized to be closely related to the development of gastrointestinal (GI) involvement in Behcet's syndrome (BS)… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Behcet's Syndrome, Intestinal Type
- What is being tested?
- Biological samples collection
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Sep 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient who have Behcet's syndrome with or without intestinal involvement, compared with inflammatory bowel disease patients and health controls.
Who may be able to join
- Behcet's syndrome patients with intestinal involvement:
- Attendance at Peking Union Medical College Hospital, fulfillment of one of the two diagnostic criteria for BS (1990 Criteria of International Study Group for Behcet's disease or 2014 International Criteria for Behçet's Disease), and well-documented medical records;
- Age 20-65 years old;
- Have evidence of GI involvement, including clinical manifestations, laboratory tests, endoscopy, imaging and pathology;
- Signed written informed consent and willingness to cooperate.
- Behcet's syndrome patients with intestinal involvement:
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- Attendance at Peking Union Medical College Hospital, fulfillment of one of the two diagnostic criteria for BS (1990 Criteria of International Study Group for Behcet's disease or 2014 International Criteria for Behçet's Disease), and well-documented medical records;
- Age 20-65 years old;
- Have no evidence of GI involvement, including clinical manifestations, laboratory tests, endoscopy, imaging and pathology;
- Signed written informed consent and willingness to cooperate.
- Inflammatory bowel disease patients:
- Attended Peking Union Medical College Hospital and was diagnosed with Crohn's disease by a combination of clinical, imaging, and pathologic diagnosis;
- Age 20-65 years old;
- Signed written informed consent and willingness to cooperate.
- Health controls:
- Healthy individuals aged 20-65 years;
- Signed written informed consent and willingness to cooperate.
Who cannot join
- Other systemic diseases, such as autoimmune diseases, infectious diseases, malignant tumors, etc;
- Patients with other intestinal diseases, such as intestinal tumors, intestinal tuberculosis, intestinal infections;
- Patients with other oral diseases, such as cavity caries, oral abscesses, oral tumors, oral candidiasis, and dry mouth;
- Patients taking antibiotics and probiotics within one month.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Dong Wu, 18612671010, wudong@pumch.cn
About this study
Official title: Exploration of the Pathogenesis of Intestinal Behcet's Syndrome: a Single-center Prospective Observational Study
There is a direct interaction between food, intestinal flora and the intestinal barrier composed of intestinal epithelial cells and mucosal immunity, whose composition and functional alterations are theorized to be closely related to the development of gastrointestinal (GI) involvement in Behcet's syndrome (BS) patients. Therefore, this study focuses on the population of patients with intestinal BS and explores the unique mechanisms leading to intestinal involvement in BS patients in terms of the characteristics of intestinal microecology. Since oral ulcers are one of the most common clinical manifestations in BS patients, in addition to intestinal flora analysis, this application project also plans to collect saliva samples from patients in the hope of obtaining a holistic understanding of mucosal flora in different parts of the entire GI tract. Serological testing and analysis will also be performed, focusing on changes in the intestinal tract and serum IgE levels, and analyzed in conjunction with microbiomics to provide evidence to further elucidate the pathogenesis of BS and GI involvement, and to search for more efficient therapeutic strategies, in terms of a variety of aspects, including clinical manifestations and disease progression.
- Conditions
- Behcet's Syndrome, Intestinal Type
- Being tested
- Biological samples collection
- Keywords
- Behcet's syndrome, intestinal Behcet's syndrome, inflammatory bowel disease, microbiome, metabolomics
- Medical subject headings
- Behcet Syndrome, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samples collectionOther
Samples of blood, faeces, saliva are collected for analysis.
| Study group | Role | What they receive |
|---|---|---|
| Behcet's syndrome patients with intestinal involvement | Not described Receives: Other: Biological samples collection | |
| Behcet's syndrome patients without intestinal involvement | Not described Receives: Other: Biological samples collection | |
| Inflammatory bowel disease patients | Not described Receives: Other: Biological samples collection | |
| Health control | Not described Receives: Other: Biological samples collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structure and composition of gut microbiota
DNA extraction from stool samples will be tested through 16S microbial sequencing and metagenomic sequencing to establish and compare microbial profiles of the gut microbiota among different groups.
Measured: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
Structure and composition of oral microbiota
DNA extraction from saliva samples will be tested through 16S microbial sequencing and metagenomic sequencing to establish and compare microbial profiles of the oral microbiota among different groups.
Measured: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
Structure and composition of metabolomics
Serum extraction from blood samples will be tested through non-targeted metabolomics techniques to analysis and compare metabolomics among different groups.
Measured: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
Serum level of Immunoglobulin E
Serum extraction from blood samples will be used to test and compare the level of IgE among different groups.
Measured: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's Syndrome, Intestinal TypeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dong Wu, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026020
- Sponsor's protocol ID
- K4434
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 6 Sep 2023
- 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 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Pathogenesis of Intestinal Behcet's Syndrome: a Single-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06026020
- Acronym / sponsor ID
- K4434
- Conditions
- Behcet's Syndrome, Intestinal Type
- Keywords
- Behcet's syndrome, intestinal Behcet's syndrome, inflammatory bowel disease, microbiome, metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 Sep 2023 (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.
There is a direct interaction between food, intestinal flora and the intestinal barrier composed of intestinal epithelial cells and mucosal immunity, whose composition and functional alterations are theorized to be closely related to the development of gastrointestinal (GI) involvement in Behcet's syndrome (BS) patients. Therefore, this study focuses on the population of patients with intestinal BS and explores the unique mechanisms leading to intestinal involvement in BS patients in terms of the characteristics of intestinal microecology. Since oral ulcers are one of the most common clinical manifestations in BS patients, in addition to intestinal flora analysis, this application project also plans to collect saliva samples from patients in the hope of obtaining a holistic understanding of mucosal flora in different parts of the entire GI tract. Serological testing and analysis will also be performed, focusing on changes in the intestinal tract and serum IgE levels, and analyzed in conjunction with microbiomics to provide evidence to further elucidate the pathogenesis of BS and GI involvement, and to search for more efficient therapeutic strategies, in terms of a variety of aspects, including clinical manifestations and disease progression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Behcet's syndrome patients with intestinal involvement | – | Other: Biological samples collection |
| Behcet's syndrome patients without intestinal involvement | – | Other: Biological samples collection |
| Inflammatory bowel disease patients | – | Other: Biological samples collection |
| Health control | – | Other: Biological samples collection |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who have Behcet's syndrome with or without intestinal involvement, compared with inflammatory bowel disease patients and health controls.
Key inclusion criteria (17 listed)
- Attendance at Peking Union Medical College Hospital, fulfillment of one of the two diagnostic criteria for BS (1990 Criteria of International Study Group for Behcet's disease or 2014 International Criteria for Behçet's Disease), and well-documented medical records;
- Age 20-65 years old;
- Have evidence of GI involvement, including clinical manifestations, laboratory tests, endoscopy, imaging and pathology;
- Signed written informed consent and willingness to cooperate.
- Attendance at Peking Union Medical College Hospital, fulfillment of one of the two diagnostic criteria for BS (1990 Criteria of International Study Group for Behcet's disease or 2014 International Criteria for Behçet's Disease), and well-documented medical records;
Key exclusion criteria (4 listed)
- Other systemic diseases, such as autoimmune diseases, infectious diseases, malignant tumors, etc;
- Patients with other intestinal diseases, such as intestinal tumors, intestinal tuberculosis, intestinal infections;
- Patients with other oral diseases, such as cavity caries, oral abscesses, oral tumors, oral candidiasis, and dry mouth;
- Patients taking antibiotics and probiotics within one month.
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 |
|---|---|---|
| Biological samples collectionSamples of blood, faeces, saliva are collected for analysis. | Other | Behcet's syndrome patients with intestinal involvement, Behcet's syndrome patients without intestinal involvement, Health control, Inflammatory bowel disease patients |
Primary outcome
Structure and composition of gut microbiota
Time frame: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
DNA extraction from stool samples will be tested through 16S microbial sequencing and metagenomic sequencing to establish and compare microbial profiles of the gut microbiota among different groups.
Structure and composition of oral microbiota
Time frame: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
DNA extraction from saliva samples will be tested through 16S microbial sequencing and metagenomic sequencing to establish and compare microbial profiles of the oral microbiota among different groups.
Structure and composition of metabolomics
Time frame: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
Serum extraction from blood samples will be tested through non-targeted metabolomics techniques to analysis and compare metabolomics among different groups.
Serum level of Immunoglobulin E
Time frame: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)
Serum extraction from blood samples will be used to test and compare the level of IgE among different groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- 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.
Dong Wu principal investigator
Peking Union Medical College Hospital
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 Behcet's Syndrome, Intestinal Type, run by Peking Union Medical College Hospital 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 17 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Wu (18612671010, wudong@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structure and composition of gut microbiota (time frame: Day 1 after addmission due to the disease activity and signing an informed consent (for patients); or day 1 after signing an informed consent (for health controls)). The study lists 4 primary outcomes in all. 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 6 Sep 2023.