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Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis

Safety and efficacy of Budesonide administration after endoscopic ballon dilation for Crohn disease patients with intestinal stenosis - Safety and efficacy of Budesonide administration after EBD for CD patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031839
Enrollment
15
Registered
2018-04-01
Start date
2018-04-01
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

At the time of resumption of food, patients recerve 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.

Sponsors

Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Lead Sponsor
Japan Community Health care Organizationi Osaka Hospital, Gastroenterology and Hepatology National Hospital Organization Osaka National Hospital, Gastroenterology and Hepatology Osaka Rosai Hospital , Gastroenterology and Hepatology Kansai Rosai Hospital, Gastroenterology and Hepatology Itami City Hospital, Gastroenterology and Hepatology Hyogo Prefectural Nishinomiya Hospital, Gastroenterology and Hepatology Nishinomiya Municipal central hospital, Gastroenterology and Hepatology
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Mild to moderate active Crohn's disease patients with written consent at Osaka University Hospital and affiliated hospitals, who have intestinal stenosis and are scheduled or recieved endoscopic balloon dilation (EBD), are included.

Exclusion criteria

Exclusion criteria: Patients with more than 5 centimeters long stenosis Patients with internal or external fistula Patients with active infection, including abscess Patients with oral treatment of antithrombotic drugs or low platelet that counts less than 50000 per microlitter Patients with cancer Patients under 20 years old Patients with severy bad general condition Patients who are administered steroids within 4 weeks Patients who are judged inapropriate by doctors

Design outcomes

Primary

MeasureTime frame
safety within 12 weeks after EBD

Secondary

MeasureTime frame
safety within 52 weeks after EBD rate of non-intestinal resection, non-reEBD and non-hospitalization rate of non-restenosis at 52 weeks after EBD

Countries

Japan

Contacts

Public ContactShinichiro Shinzaki

Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology

shinzaki@gh.med.osaka-u.ac.jp06-6879-3621

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026