NCT02190357

Brief Summary

Cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and increased intestinal permeability all leading to an increase in bacterial translocation and increased endotoxemia. Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract. It has been suggested that oral prophylactic antibiotics or bowel decontamination might improve long-term outcomes in patients with cirrhosis. The aim of this study was to explore the effect of rifaximin on the complications of advanced cirrhosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

4 years

First QC Date

July 10, 2014

Last Update Submit

September 12, 2016

Conditions

Cirrhosis

Keywords

Cirrhosis

Outcome Measures

Primary Outcomes (4)

  • number of death

    6 months

  • numbers of liver transplantation

    6 months

  • numbers of hepatic encephalopathy

    6 months

  • Numbers of other complications of cirrhosis

    6 months

Study Arms (2)

rifaximin

EXPERIMENTAL

400 mg bid,orally

Drug: Rifaximin

controlled group

NO INTERVENTION

no intervention

Interventions

RifaximinDRUG

Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract.

rifaximin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Related Publications (5)

  • Mullen KD, Sanyal AJ, Bass NM, Poordad FF, Sheikh MY, Frederick RT, Bortey E, Forbes WP. Rifaximin is safe and well tolerated for long-term maintenance of remission from overt hepatic encephalopathy. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1390-7.e2. doi: 10.1016/j.cgh.2013.12.021. Epub 2013 Dec 21.

    PMID: 24365449RESULT

  • Xu D, Gao J, Gillilland M 3rd, Wu X, Song I, Kao JY, Owyang C. Rifaximin alters intestinal bacteria and prevents stress-induced gut inflammation and visceral hyperalgesia in rats. Gastroenterology. 2014 Feb;146(2):484-96.e4. doi: 10.1053/j.gastro.2013.10.026. Epub 2013 Oct 22.

    PMID: 24161699RESULT

  • Lutz P, Parcina M, Bekeredjian-Ding I, Hoerauf A, Strassburg CP, Spengler U. Spontaneous bacterial peritonitis by Pasteurella multocida under treatment with rifaximin. Infection. 2014 Feb;42(1):175-7. doi: 10.1007/s15010-013-0449-4. Epub 2013 Mar 25.

    PMID: 23526308RESULT

  • Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

    PMID: 37467180DERIVED

  • Zeng X, Sheng X, Wang PQ, Xin HG, Guo YB, Lin Y, Zhong JW, He CZ, Yin J, Liu TT, Ma WJ, Xiao X, Shi PM, Yuan ZL, Yang L, Ma X, Xu JM, Shen XZ, Yang CQ, Zhu X, Lv NH, Xie WF. Low-dose rifaximin prevents complications and improves survival in patients with decompensated liver cirrhosis. Hepatol Int. 2021 Feb;15(1):155-165. doi: 10.1007/s12072-020-10117-y. Epub 2021 Jan 1.

    PMID: 33385299DERIVED

MeSH Terms

Conditions

Fibrosis

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Wei-Fen Xie, MD

    Department of Gastroenterology, Changzheng Hospital, Second Military Medical University, Shanghai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Fen Xie, MD

CONTACT

86-21-81885341coss2008@yeah.net

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 15, 2014

Study Start

August 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2019

Last Updated

September 14, 2016

Record last verified: 2016-09

Locations

CN(1)