Pathogenesis of Intestinal Behcet's Syndrome

Last updated: September 3, 2023
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lupus

Treatment

Biological samples collection

Clinical Study ID

NCT06026020
K4434
  • Ages 20-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Behcet's syndrome patients with intestinal involvement:

  • Attendance at Peking Union Medical College Hospital, fulfillment of one of the twodiagnostic criteria for BS (1990 Criteria of International Study Group for Behcet'sdisease or 2014 International Criteria for Behçet's Disease), and well-documentedmedical 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 twodiagnostic criteria for BS (1990 Criteria of International Study Group for Behcet'sdisease or 2014 International Criteria for Behçet's Disease), and well-documentedmedical records;
  • Age 20-65 years old;
  • Have no evidence of GI involvement, including clinical manifestations, laboratorytests, 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 diseaseby 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

Exclusion Criteria:

  • Other systemic diseases, such as autoimmune diseases, infectious diseases, malignanttumors, etc;
  • Patients with other intestinal diseases, such as intestinal tumors, intestinaltuberculosis, 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 Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Biological samples collection
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

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