Small Bowel Endoscopic Healing by Biologics in Patients with Crohn's Disease

Small Bowel Endoscopic Healing by Biologics in Patients with Crohn's Disease - SEBIO study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000038624

Enrollment

240

Registered

2019-12-01

Start date

2020-02-01

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

Crohn&#39

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients who is diagnosed as ileocolonic or ileal Crohn's disease 2.Patients who are considering starting or changing treatment with biologics (infliximab, adalimumab, ustekinumab, vedolizumab) 3. Patients who have small bowel ulceration on Balloon-assisted enteroscopic examination

Exclusion criteria

Exclusion criteria: 1.Patients with purely colonic Crohn's disease 2.Patients who had undergone colostomy or ileostomy. 3.Patients who could not underwent balloon enteroscopy because of strictures 4.Patients expected to undergo small bowel surgery in the near future 5.Current gastrointestinal infection 6.History of malignant disease 7.Patients suffering from tuberculosis, hepatitis B or C. 8.Pregnancy 9.Unable to sign informed consent

Design outcomes

Primary

Measure	Time frame
Endoscopic remission (mSES-CD<4) at week 26	—

Secondary

Measure	Time frame
Complete mucosal healing at week 26 Endoscopic response (reduction in mSES-CD by 50% or more) at week 26 Risk factor for the primary outcome measures PK of biologics Clinical remission and Biological remission at week 26	—

Countries

Japan

Contacts

Public ContactKento Takenaka

Tokyo Medical and Dental University Gastroenterology and Hepatology

sebio.gast@tmd.ac.jp03-5803-5877

Outcome results