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Rifaximin in Patients With Gastroesophageal Variceal Bleeding (RFXM)

Primary Purpose

Cirrhosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rifaximin
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 180 Fenglin Road

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rifaximin Treatment Group

Control Group

Arm Description

Rifaximin 400mg bid for 2 months,

Receive routine endoscopic treatment without having rifaximin for 2 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes of portal vein thrombosis
complete or partial recanalization of thrombosis
Changes of intestinal flora
Metagenomics sequencing
The changes of serum level of cytokines
Cytokines including TNF-α, IL-1β, IL-2R, IL-6 and IL-10, etc

Full Information

First Posted
December 10, 2016
Last Updated
May 4, 2018
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02991612
Brief Title
Rifaximin in Patients With Gastroesophageal Variceal Bleeding
Acronym
RFXM
Official Title
Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 25, 2016 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin Treatment Group
Arm Type
Experimental
Arm Description
Rifaximin 400mg bid for 2 months,
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Receive routine endoscopic treatment without having rifaximin for 2 months
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
XIFAXAN
Intervention Description
Patients receive Rifaximin 400mg bid for 2 months
Primary Outcome Measure Information:
Title
Incidence of all clinical adverse events
Description
The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Changes of portal vein thrombosis
Description
complete or partial recanalization of thrombosis
Time Frame
2 months
Title
Changes of intestinal flora
Description
Metagenomics sequencing
Time Frame
2 months
Title
The changes of serum level of cytokines
Description
Cytokines including TNF-α, IL-1β, IL-2R, IL-6 and IL-10, etc
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyao CHEN, M.D.
Organizational Affiliation
Zhongshan Hospital, Fudan University, Shanghai
Official's Role
Principal Investigator
Facility Information:
Facility Name
180 Fenglin Road
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

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Rifaximin in Patients With Gastroesophageal Variceal Bleeding

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