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Rifaximin in Patients With Gastroesophageal Variceal Bleeding (RFXM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991612
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Shiyao Chen, Shanghai Zhongshan Hospital

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

Condition or disease Intervention/treatment Phase
Cirrhosis Esophageal and Gastric Varices Gastrointestinal Hemorrhage Drug: Rifaximin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Rafiximin in Patients With Cirrhotic Gastroesophageal Variceal Hemorrhage: A Single-center Pilot Study
Actual Study Start Date : November 25, 2016
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Rifaximin

Arm Intervention/treatment
Experimental: Rifaximin Treatment Group
Rifaximin 400mg bid for 2 months,
Drug: Rifaximin
Patients receive Rifaximin 400mg bid for 2 months
Other Name: XIFAXAN

No Intervention: Control Group
Receive routine endoscopic treatment without having rifaximin for 2 months



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991612


Locations
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China, Shanghai
180 Fenglin Road
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Principal Investigator: Shiyao CHEN, M.D. Zhongshan Hospital, Fudan University, Shanghai
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Responsible Party: Shiyao Chen, Professor, Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02991612    
Other Study ID Numbers: ZS-CSY-RFXM
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Esophageal and Gastric Varices
Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Esophageal Diseases
Hypertension, Portal
Liver Diseases
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents