NCT02675153

To Evaluate the Efficacy and Safety of Rapamycin for Crohn's Disease-related Stricture

Efficacy and Safety of Rapamycin in the Treatment of Crohn's Disease-related Stricture

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Crohn's disease （CD） with stenosis has limited therapeutic options and with high surgical rate. The present clinical trial aims to evaluate the efficacy and safety of rapamycin in the treatment of stricturing Crohn's Disease.

Detailed description

Management of Crohn's disease （CD） with stenosis is challenging and often requires endoscopic dilatation or surgical resection of the strictured bowel. Sirolimus (rapamycin), a macrocyclic antibiotic with immunosuppressive and antineoplastic properties, has been reported as promising rescue therapy for refractory CD. This study aims to evaluate the use of sirolimus for stricturing Crohn's Disease. Patients in this study will receive a continuous dosing schedule of oral sirolimus 2mg daily for six months. Clinical responses were defined as the ability to tolerate the regular diet with vegetable fiber combined with a reduction of ≥ 75% in overall target score and a score of less than two points for each item.

Conditions

• Crohn's Diseases

Interventions

Type	Name	Description
DRUG	Rapamycin	Participants with gastrointestinal strictures were treated with rapamycin 2mg daily at least six months.

Timeline

• Start date: 2015-04-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2016-02-05
• Last updated: 2020-10-08

Locations

1 site across 1 country: China