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

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. Identifier: NCT01769040
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : January 20, 2016
Region MidtJylland Denmark
Statens Serum Institut
Information provided by (Responsible Party):
Nina Kimer, Copenhagen University Hospital, Hvidovre

Brief Summary:

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 or disease Intervention/treatment Phase
Liver Cirrhosis Ascites Drug: Rifaximin Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
Drug Information available for: Rifaximin

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in Hepatic venous pressure gradient (HVPG) [ Time Frame: 29 days ]
    Evaluation of a change in HVPG where values at baseline are compared to values after treatment at 29 days.

Secondary Outcome Measures :
  1. Change from baseline in Glomerular filtration rate (GFR) [ Time Frame: 29 days ]
    Assessment of a change in GFR from baseline until after treatment, at 29 days

Other Outcome Measures:
  1. Change from baseline of inflammatory markers (TNF-alpha, interleukins, etc.) [ Time Frame: day 29 ]
    Inflammatory markers measured in arterial blood before and after intervention.

  2. Change from baseline of potential small intestinal bacterial overgrowth [ Time Frame: days 28-30 ]
    Assessment of bacterial overgrowth by glucose breath test and bacterial DNA in blood and stool.

  3. six-month mortality and comorbidity [ Time Frame: 180 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01769040

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Copenhagen University hospital Hvidovre
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Copenhagen University Hospital, Hvidovre
Region MidtJylland Denmark
Statens Serum Institut
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Principal Investigator: Nina Kimer, MD Department of Gastroenterology, Cpenhagen University Hospital Hvidovre
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Nina Kimer, MD, Phd-student, Copenhagen University Hospital, Hvidovre Identifier: NCT01769040    
Other Study ID Numbers: RifaxNK150612
2012-002890-71 ( EudraCT Number )
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Keywords provided by Nina Kimer, Copenhagen University Hospital, Hvidovre:
Decompensated liver cirrhosis
Small intestinal bacterial overgrowth
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents