Pathogenesis of Intestinal Behcet's Syndrome

September 3, 2023 updated by: Peking Union Medical College Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Structure and composition of gut microbiota
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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 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
Time Frame: 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 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dong Wu, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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