Rifaximin in Patients With Gastroesophageal Variceal Bleeding

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

Detailed Description
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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.

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

Conditions
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Cirrhosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage

Intervention / Treatment
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* Drug: Rifaximin


Participation Criteria
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Eligibility Criteria
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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

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rifaximin Treatment Group<br>Rifaximin 400mg bid for 2 months, | Drug: Rifaximin<br>* Patients receive Rifaximin 400mg bid for 2 months<br>* Other names: XIFAXAN;|
| No Intervention: Control Group<br>Receive routine endoscopic treatment without having rifaximin for 2 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 weeks | 

Secondary Outcome Measures

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