Intestinal Decontamination With Rifaximin. The Inflammatory and Circulatory State in Patients With Cirrhosis
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.
|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|
- 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.
- 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
- 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 ]
|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)|
Rifaximin tablets for oral ingestion, 550 mg twice daily for 28 days.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01769040
|Copenhagen University hospital Hvidovre||Recruiting|
|Hvidovre, Denmark, 2650|
|Contact: Nina Kimer, MD +45 38 62 31 81 firstname.lastname@example.org|
|Contact: Flemming Bendtsen, DmSC email@example.com|
|Principal Investigator: Nina Kimer, MD|
|Sub-Investigator: Søren Møller, DmSC|
|Principal Investigator:||Nina Kimer, MD||Department of Gastroenterology, Cpenhagen University Hospital Hvidovre|