Understanding the causes of intestinal Behcet's syndrome

Exploration of the Pathogenesis of Intestinal Behcet's Syndrome: a Single-center Prospective Observational Study

This study looks at how diet and gut bacteria affect the symptoms of intestinal Behcet's syndrome to help understand the condition better.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 20 Years to 65 Years
• Sex: All
• Sponsor: Peking Union Medical College Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT06026020 on ClinicalTrials.gov

What this trial studies

This observational study investigates the mechanisms behind gastrointestinal involvement in patients with intestinal Behcet's syndrome. It focuses on the interaction between diet, intestinal flora, and the intestinal barrier, analyzing how these factors contribute to the disease. The study will collect biological samples, including saliva and serum, to assess the characteristics of intestinal microecology and changes in mucosal immunity. By examining these elements, researchers aim to gain a comprehensive understanding of the condition.

Who should consider this trial

Good fit: Ideal candidates are patients aged 20-65 with a confirmed diagnosis of Behcet's syndrome and evidence of gastrointestinal involvement.

Not a fit: Patients with Behcet's syndrome who do not exhibit gastrointestinal involvement may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management and treatment strategies for patients with intestinal Behcet's syndrome.

How similar studies have performed: While the specific approach of this study is novel, similar studies have shown promise in understanding the role of microbiome and immune responses in inflammatory bowel diseases.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing

• Peking Union Medical College Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Dong Wu — Peking Union Medical College Hospital
• Study coordinator: Dong Wu

Conditions Behcet's Syndrome, Intestinal Type; Behcet's syndrome; intestinal Behcet's syndrome; inflammatory bowel disease; microbiome; metabolomics