Back to resultsRifaximin 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
About this trial
This is an interventional treatment trial for Cirrhosis
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
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
NCT ID
NCT02991612
First Posted
December 10, 2016
Last Updated
May 4, 2018
Sponsor
Shanghai Zhongshan Hospital
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
Learn more about this trial
Rifaximin in Patients With Gastroesophageal Variceal Bleeding
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