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

JRCT ID: jRCT1051190043

Registered date:02/09/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Crohn's disease
• Date of first enrollment: 20/12/2018
• Target sample size: 15
• Study type: Interventional
• Intervention(s): At the time of resumption of food after endoscopic balloon dilation, patients receive 9mg/day budesonide orally for 3 weeks, followed by 6mg/day for 1 week.

Outcome(s)

• Primary Outcome: Safety within 12 weeks after EBD

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include 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.

Exclude 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

Related Information

• Primary Sponsor: Takehara Tetsuo
• Secondary Sponsor: Iijima Hideki
• Secondary ID(s): UMIN000031839