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Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With Cirrhosis

This study is currently recruiting participants.
Verified January 2013 by Copenhagen University Hospital, Hvidovre
Sponsor:
Collaborators:
Norgine
Region MidtJylland Denmark
Statens Serum Institut
Information provided by (Responsible Party):
Nina Kimer, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier:
NCT01769040
First received: January 8, 2013
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

This investigational trial will be assessing the effect of rifaximin on pathophysiology and haemodynamics in the patient with liver cirrhosis, and addressing the effect of rifaximin on several organs on marker level. The molecular and physiological effects of rifaximin will be explored.

The investigators hypothesize that intestinal decontamination with rifaximin in patients with cirrhosis and ascites will interrupt bacterial translocation from the gut, diminish the following inflammatory response, prevent splanchnic vasodilatation and portal systemic contraction and thereby reduce the risk clinical complications to cirrhosis.

If rifaximin can correct small intestinal bacterial overgrowth and demonstrate improvement in liver haemodynamics, renal function and systemic dynamics, then these effects may contribute to the overall well-being of the patient and prevent complications to the underlying cirrhosis such as risk of infections, progression of disease, and admission to hospital.


Condition Intervention Phase
Liver Cirrhosis
Ascites
 Drug: Rifaximin
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Intestinal Decontamination With Rifaximin. Effects on the Inflammatory and Circulatory State in Patients With Cirrhosis and Ascites - A Randomised Controlled Clinical Study

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
Drug Information available for: Rifaximin
U.S. FDA Resources

Further study details as provided by Copenhagen University Hospital, Hvidovre:

Primary Outcome Measures:
  • Change from baseline in Hepatic venous pressure gradient (HVPG) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Evaluation of a change in HVPG where values at baseline are compared to values after treatment at 29 days.


Secondary Outcome Measures:
  • Change from baseline in Glomerular filtration rate (GFR) [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    Assessment of a change in GFR from baseline until after treatment, at 29 days


Other Outcome Measures:
  • Change from baseline of inflammatory markers (TNF-alpha, interleukins, etc.) [ Time Frame: day 29 ] [ Designated as safety issue: No ]
    Inflammatory markers measured in arterial blood before and after intervention.

  • Change from baseline of potential small intestinal bacterial overgrowth [ Time Frame: days 28-30 ] [ Designated as safety issue: No ]
    Assessment of bacterial overgrowth by glucose breath test and bacterial DNA in blood and stool.

  • six-month mortality and comorbidity [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 57
Study Start Date: November 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifaximin
Rifaximin tablets for oral ingestion, 550 mg twice daily for 28 days.
 Drug: Rifaximin
550 mg two times daily for 28 days
Other Name: Xifaxan
Placebo Comparator: Placebo tablets
Placebo tablets similar in shape and size to intervention treatment, 1 tablet twice daily for 28 days.
 Drug: placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Decompensated liver cirrhosis and clinical signs of ascites
  • Age 18 - 80 years
  • Portal hypertension and hepatic venous pressure gradient (HVPG) of 10 mmHg or more
  • Women of child-bearing age must use safe anticonception, either hormonal anticonception or intrauterine device (IUD)

Exclusion Criteria:

  • Child-Pugh score above 12
  • Clinical signs of infection or biochemical signs of infection with leucocytes > 10x10'9/L and C-Reactive Protein (CRP)> 20 or positive urine culture
  • Hepatocellular carcinoma within the last year
  • Invasive cancer within the last five years
  • Hepatic encephalopathy above grade 1
  • serum creatinine > 200 micromoles/L
  • Transfusion requiring bleeding one week prior to inclusion
  • severe cardiac, pulmonary or kidney disease or IDDM
  • alcohol abuse and symptoms of abstinences
  • Expected survival less than 3 months
  • Denied consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769040

Locations
Denmark
Copenhagen University hospital Hvidovre Recruiting
Hvidovre, Denmark, 2650
Contact: Nina Kimer, MD     +45 38 62 31 81     nina.kimer@regionh.dk    
Contact: Flemming Bendtsen, DmSC         flemming.bendtsen@regionh.dk    
Principal Investigator: Nina Kimer, MD            
Sub-Investigator: Søren Møller, DmSC            
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Norgine
Region MidtJylland Denmark
Statens Serum Institut
Investigators
Principal Investigator: Nina Kimer, MD Department of Gastroenterology, Cpenhagen University Hospital Hvidovre
  More Information

No publications provided

Responsible Party: Nina Kimer, MD, Phd-student, Copenhagen University Hospital, Hvidovre
ClinicalTrials.gov Identifier: NCT01769040     History of Changes
Other Study ID Numbers: RifaxNK150612, 2012-002890-71
Study First Received: January 8, 2013
Last Updated: January 14, 2013
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by Copenhagen University Hospital, Hvidovre:
Decompensated liver cirrhosis
Ascites
Haemodynamics
Small intestinal bacterial overgrowth
Pathophysiology

Additional relevant MeSH terms:
Ascites
Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
 Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on June 18, 2013