A multi-center observational study for validation to establish severity criteria for intestinal Behcet's disease.

A multi-center observational study for validation to establish severity criteria for intestinal Behcet's disease. - Multi-center observational study to establish severity criteria for intestinal Behcet's disease.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049488

Enrollment

200

Registered

2022-11-14

Start date

2022-07-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intestinal Behcet&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed by the Ministry of Health, Labor and Welfare research group Behcet's disease diagnostic criteria or clinically diagnosed as (intestinal) Behcet's disease and patients with simple ulcers.

Exclusion criteria

Exclusion criteria: 1) Patients who are judged to be inappropriate as subjects by the judgment of researchers. 2) Those who refused to participate in this study. 3) Atypical cases without ileo-cecal lesions.

Design outcomes

Primary

Measure	Time frame
Relationship between severity assessment and subsequent hospitalization or surgery rate in patients with intestinal Behcet's disease.	—

Secondary

Measure	Time frame
1) Relationship between severity at diagnosis and Disease Activity Index for Intestinal BD (DAIBD). 2) Relationship between severity at assessment and serological severity. 3) The relationship between the severity at the time of judgment and the treatment newly added within 1 month and 3 months after the judgment at the time of severity judgment. 4) Treatment responsiveness when therapeutic intervention is performed in 3). 5) Relationship between severity at time of diagnosis and time to hospitalization after diagnosis. 6) Relationship between the severity at the time of judgment and the period until surgery is required after judgment. 7) Relationship between severity at judgment and clinical background other than the above.	—

Measure

Time frame

1) Relationship between severity at diagnosis and Disease Activity Index for Intestinal BD (DAIBD). 2) Relationship between severity at assessment and serological severity. 3) The relationship between the severity at the time of judgment and the treatment newly added within 1 month and 3 months after the judgment at the time of severity judgment. 4) Treatment responsiveness when therapeutic intervention is performed in 3). 5) Relationship between severity at time of diagnosis and time to hospitalization after diagnosis. 6) Relationship between the severity at the time of judgment and the period until surgery is required after judgment. 7) Relationship between severity at judgment and clinical background other than the above.

—

Countries

Japan

Contacts

Public ContactToshiro Fukui

Kansai Medical University Hospital Department of Gastroenterology and Hepatology

fukuitos@hirakata.kmu.ac.jp072-804-0101

Outcome results