Pathogenesis of Intestinal Behcet's Syndrome

NCT06026020 | Unknown

• 1 other identifier: K4434
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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) 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

Keywords

Behcet's syndrome; intestinal Behcet's syndrome; inflammatory bowel disease; microbiome; metabolomics

Outcome Measures

Primary Outcomes (4)

• 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)

Study Arms (4)

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

Interventions

Biological samples collection OTHER

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

Behcet's syndrome patients with intestinal involvement; Behcet's syndrome patients without intestinal involvement; Health control; Inflammatory bowel disease patients

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Behcet Syndrome; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Dong Wu

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Wu

CONTACT

18612671010; wudong@pumch.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)