Pathogenesis of Intestinal Behcet's Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Behcet's Syndrome, Intestinal Type
• Intervention / Treatment: Other: Biological samples collection

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Dong Wu; Phone Number: 18612671010; Email: wudong@pumch.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Dong Wu; Phone Number: 18612671010; Email: wudong@pumch.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patient who have Behcet's syndrome with or without intestinal involvement, compared with inflammatory bowel disease patients and health controls.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Health control	Other: Biological samples collection; Samples of blood, faeces, saliva are collected for analysis.
Behcet's syndrome patients with intestinal involvement	Other: Biological samples collection; Samples of blood, faeces, saliva are collected for analysis.
Behcet's syndrome patients without intestinal involvement	Other: Biological samples collection; Samples of blood, faeces, saliva are collected for analysis.
Inflammatory bowel disease patients	Other: Biological samples collection; Samples of blood, faeces, saliva are collected for analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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)

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Dong Wu, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 17, 2023
• First Submitted That Met QC Criteria: September 3, 2023
• First Posted (Actual): September 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: microbiome; inflammatory bowel disease; metabolomics; Behcet's syndrome; intestinal Behcet's syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Eye Diseases; Disease; Genetic Diseases, Inborn; Stomatognathic Diseases; Mouth Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Vasculitis; Hereditary Autoinflammatory Diseases; Skin Diseases, Genetic; Skin Diseases, Vascular; Syndrome; Behcet Syndrome
• Other Study ID Numbers: K4434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No