Rifaximin in Patients With Gastroesophageal Variceal Bleeding (RFXM)

May 4, 2018 updated by: Shiyao Chen, Shanghai Zhongshan Hospital

Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study

The purpose of the study is to evaluate the safety and efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastroesophageal variceal bleeding is the most common and life-threatening condition in patients with portal hypertension, which are susceptibility to bacterial infection.

However, the prophylaxis use of antibiotics remained uncertain and lack of high level evidences.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • 180 Fenglin Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 y.o. ≤age≤75 y.o.;
  • Cirrhotic gastroesophageal variceal bleeding underwent endoscopic treatment (include esophageal varices ligation, endoscopic injection sclerosis and gastric N- butyl-cyanoacrylate injection).

Exclusion Criteria:

  • age <18 y.o. or age > 75 y.o.;
  • Never had the variceal bleeding episode before;
  • Do not have endoscopic treatment;
  • Combined with other malignant tumors (not exclude patients with hepatocellular carcinoma who don't need treatment at the moment);
  • Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.)
  • Massive ascites or combined with other high-risk factors that require prophylaxis use of antibiotics.
  • Acute variceal bleeding within 5 days.
  • Refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rifaximin Treatment Group
Rifaximin 400mg bid for 2 months,
Drug: Rifaximin
Patients receive Rifaximin 400mg bid for 2 months
Other Names:
  • XIFAXAN
NO_INTERVENTION: Control Group
Receive routine endoscopic treatment without having rifaximin for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of all clinical adverse events
Time Frame: 8 weeks
The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of portal vein thrombosis
Time Frame: 2 months
complete or partial recanalization of thrombosis
2 months
Changes of intestinal flora
Time Frame: 2 months
Metagenomics sequencing
2 months
The changes of serum level of cytokines
Time Frame: 8 weeks
Cytokines including TNF-α, IL-1β, IL-2R, IL-6 and IL-10, etc
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 25, 2016

Primary Completion (ACTUAL)

December 22, 2017

Study Completion (ACTUAL)

February 28, 2018

Study Registration Dates

First Submitted

December 10, 2016

First Submitted That Met QC Criteria

December 10, 2016

First Posted (ESTIMATE)

December 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2018

Last Update Submitted That Met QC Criteria

May 4, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZS-CSY-RFXM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cirrhosis

Clinical Trials on Rifaximin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe