Rifaximin in Patients With Gastroesophageal Variceal Bleeding

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02991612

Acronym

RFXM

Enrollment

Registered

2016-12-13

Start date

2016-11-25

Completion date

2018-02-28

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Esophageal and Gastric Varices, Gastrointestinal Hemorrhage

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.

Interventions

DRUGRifaximin

Patients receive Rifaximin 400mg bid for 2 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026