UnknownNot Applicable

Pathogenesis of Intestinal Behcet's Syndrome

China80 participantsStarted 2023-09

Plain-language 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.

Who can participate

Age range20 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. Excl…

What they're measuring

Structure and composition of gut microbiota

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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)

Trial details

NCT IDNCT06026020

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-09

Contact for this trial

Dong Wu

18612671010 wudong@pumch.cn

View on ClinicalTrials.gov More Behcet's Syndrome, Intestinal Type trials

Plain-language summary

Who can participate

Age range20 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Structure and composition of gut microbiota

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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)