NCT02074280

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 suitable dose of rifaximin to alleviate endotoxemia and prevent 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
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Oct 2013

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

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 28, 2014

Status Verified

February 1, 2014

Enrollment Period

8 months

First QC Date

February 15, 2014

Last Update Submit

February 26, 2014

Conditions

Cirrhosis

Keywords

rifaximinendotoxemiacirrhosisadvanced cirrhosis

Outcome Measures

Primary Outcomes (3)

  • Serum endotoxin level

    4 weeks

  • Hydrogen breath test

    4 weeks

  • Fecal flora

    4 weeks

Secondary Outcomes (3)

  • Liver biochemistry tests

    4 weeks

  • Numbers of complications of cirrhosis

    4 weeks

  • Serum levels of inflammatory factors

    4 weeks

Study Arms (3)

high dose of rifaximin

EXPERIMENTAL

rifaximin 600 mg, bid, orally, 2 weeks and conventional treatment

Drug: rifaximin

low dose of rifaximin

EXPERIMENTAL

rifaximin 400 mg bid,orally, 2 weeks

Drug: rifaximin

control

NO INTERVENTION

conventional treatment

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.

high dose of rifaximinlow dose of rifaximin

Eligibility Criteria

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

You may qualify if:

  • Decompensated cirrhosis
  • Child-Pugh B or C stage

You may not qualify if:

  • severe complications of cirrhosis in the past one month.
  • renal dysfunction.
  • administration of antibiotics in the past two weeks.
  • malignant tumors.
  • HIV infection.
  • severe heart and lung disease
  • sensitivity to rifaximin
  • Pregnancy and lactation woman
  • Patients who have took part in other clinical trials in the past three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

RECRUITING

Related Publications (3)

  • 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: 24365449BACKGROUND

  • 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: 24161699BACKGROUND

  • 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: 23526308BACKGROUND

MeSH Terms

Conditions

FibrosisEndotoxemia

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBacteremiaSepsisInfectionsToxemiaSystemic Inflammatory Response SyndromeInflammation

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

86-21-81885346coss2008@yeah.net

Study Design

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

Study Record Dates

First Submitted

February 15, 2014

First Posted

February 28, 2014

Study Start

October 1, 2013

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

February 28, 2014

Record last verified: 2014-02

Locations

CN(1)