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

Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03185611

Enrollment

120

Registered

2017-06-14

Start date

2017-05-18

Completion date

2018-07-31

Last updated

2017-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Brief 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 combined with thiopurine on preventing postoperative endoscopic recurrence in Crohn's disease, compared with thiopurine. The primary endpoint is the rate of endoscopic recurrence at 6 months.

Interventions

DRUGRifaximin

Antibiotics

DRUGAzathioprine

immunomodulator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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 must have one or more 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. Intolerant of thiopurine drugs; 6. With contraindication of using rifaximin or thiopurine drugs.

Design outcomes

Primary

Measure	Time frame	Description
difference of incidence of endoscopic recurrence	6 months after surgery	Endoscopic recurrence was defined by a score ≥i2 according to endoscopic recurrence score developed by Rutgeerts et al.

Secondary

Measure	Time frame	Description
Adverse effect	6 months after surgery	Adverse effect of Rifaximin

Countries

China

Contacts

Primary ContactXiang Gao, MD, PhD

gaoxiangmed@163.com020-38663423

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026