Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Effectiveness of Rifaximin on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients Without Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03185624
• Other study ID #: 2017-ZSLY-07
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 11, 2017
• Last updated: July 18, 2017
• Start date: July 25, 2017
• Est. completion date: July 31, 2018

Study information

• Verified date: June 2017
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Xiang Gao, MD, PhD
• Phone: 020-38663423
• Email: gaoxiangmed[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Some studies have shown that rifaximin is effective in the management of Crohn's Disease. Meanwhile, its adverse effect is tolerable. But no study has been conducted to assess its effect on preventing postoperative recurrence. Thus, we conduct a randomised controlled study to assess the effect of rifaximin on preventing postoperative endoscopic recurrence in Crohn's disease. The primary endpoint is the rate of endoscopic recurrence at 6 months.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Consecutive patients with Crohn's disease undergoing intestinal resection of all macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis;

2. Enrolled patients without risk factor for the development of postoperative recurrence including penetrating disease behaviour, prior bowel resection, and active smoking.

Exclusion Criteria:

1. Severe comorbidities;

2. With a stoma;

3. With malignancy;

4. Pregnancy;

5. With contraindication of using rifaximin.

Related Conditions & MeSH terms

• Crohn Disease
• Recurrence

Intervention

Drug:
• Rifaximin
Antibiotics

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (7)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University	First Affiliated Hospital, Sun Yat-Sen University, Peking Union Medical College Hospital, RenJi Hospital, Shanghai 10th People's Hospital, Sir Run Run Shaw Hospital, Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference of incidence of endoscopic recurrence	Endoscopic recurrence was defined by a score =i2 according to endoscopic recurrence score developed by Rutgeerts et al.	6 months after surgery
Secondary	Adverse effect	Adverse effect of Rifaximin	6 months after surgery