Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Bleeding

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the 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. The purpose of the study is to evaluate the efficacy of Rifaximin in the treatment of cirrhotic gastroesophageal variceal bleeding.

Official Title
-----------------
Efficacy of Rifaximin in Treatment of Cirrhotic Gastroesophageal Variceal Hemorrhage: A Multi-center Randomized Controlled Clinical Trial

Conditions
-----------------
Cirrhosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage

Intervention / Treatment
-----------------
* Drug: Rifaximin


Participation Criteria
=================
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 tumor (not exclude patients with hepatocellular carcinoma who don't not need treatment at the moment); Known infection after endoscopic treatment (Fever, microbial cultures positive, et al.) Massive ascites or combined with other high risk factor that require prophylaxis use of antibiotics. Acute variceal bleeding within 5 days. Use of other antibiotics in the past 2 weeks; Refuse to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifaximin Group<br>Rifaximin 400 mg bid for 2 month, | Drug: Rifaximin<br>* ALFA WASSERMANN S.p.A.<br>* Other names: XIFAXAN;|
| No Intervention: Control<br>Routine endoscopic treatment without prophylactic use of antibiotics | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All clinical events | All clinical events were defined as occurrence rebreeding, ascitic fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All clinical events | All clinical events were defined as occurrence rebreeding, ascitic fluid infection, or death. | 6 months | 
| Serum endotoxin, |  | 8 weeks, and 6 months | 
| coagulation function |  | 8 weeks, and 6 months | 
| inflammatory factors including IL-6, IL-8, TNF-a, IL-1beta |  | 8 weeks, and 6 months | 
| Glucose breath hydrogen test |  | 8 weeks, and 6 months | 
| changes of intestinal flora |  | 8 weeks, and 6 months |