Pathogenesis of Intestinal Behcet's Syndrome

NCT ID: NCT06026020

Last Updated: 2023-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-30

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Behcet's Syndrome, Intestinal Type

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Behcet's syndrome patients with intestinal involvement

Biological samples collection

Intervention Type OTHER

Samples of blood, faeces, saliva are collected for analysis.

Behcet's syndrome patients without intestinal involvement

Biological samples collection

Intervention Type OTHER

Samples of blood, faeces, saliva are collected for analysis.

Inflammatory bowel disease patients

Biological samples collection

Intervention Type OTHER

Samples of blood, faeces, saliva are collected for analysis.

Health control

Biological samples collection

Intervention Type OTHER

Samples of blood, faeces, saliva are collected for analysis.

Interventions

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Biological samples collection

Samples of blood, faeces, saliva are collected for analysis.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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:

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dong Wu

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dong Wu

Role: CONTACT

18612671010

Facility Contacts

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Dong Wu

Role: primary

18612671010

Other Identifiers

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K4434

Identifier Type: -

Identifier Source: org_study_id

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