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

NCT ID: NCT03185624

Last Updated: 2017-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-25

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rifaximin

Prescribed Rifaximin (600mg, twice daily) for 3 months after surgery

Group Type EXPERIMENTAL

Rifaximin

Intervention Type DRUG

Antibiotics

Blank control

No intervention after surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Rifaximin

Antibiotics

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

Xijing Hospital

OTHER

Sponsor Role collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Xiang Gao, MD, PhD

Role: CONTACT

020-38663423

Facility Contacts

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Xiang Gao, MD, PhD

Role: primary

020-38663423

Other Identifiers

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2017-ZSLY-07

Identifier Type: -

Identifier Source: org_study_id

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