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Completed

NCT Number: NCT02991612

Rifaximin in Patients With Gastroesophageal Variceal Bleeding

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

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Key information

Conditions

Cirrhosis Digestive System Diseases Esophageal Diseases Esophageal and Gastric Varices Fibrosis Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rifaximin

Drug

Patients receive Rifaximin 400mg bid for 2 months

Other names: XIFAXAN

Primary outcomes

  1. Incidence of all clinical adverse events

    Time frame: 8 weeks

    The occurrence of rebleeding, ascites fluid infection, hepatorenal syndrome, hepatopulmonary syndrome, portal vein thrombosis, or death in 8 weeks

Secondary outcomes

  1. Changes of portal vein thrombosis

    Time frame: 2 months

    complete or partial recanalization of thrombosis

  2. Changes of intestinal flora

    Time frame: 2 months

    Metagenomics sequencing

  3. The changes of serum level of cytokines

    Time frame: 8 weeks

    Cytokines including TNF-α, IL-1β, IL-2R, IL-6 and IL-10, etc

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

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

Acronym: RFXM

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 13, 2016
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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