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.|
|ClinicalTrials.gov Identifier: NCT01769040|
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : January 20, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|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|
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.
- 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.
- 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
- Change from baseline of inflammatory markers (TNF-alpha, interleukins, etc.) [ Time Frame: day 29 ]Inflammatory markers measured in arterial blood before and after intervention.
- 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.
- six-month mortality and comorbidity [ Time Frame: 180 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT01769040
|Copenhagen University hospital Hvidovre|
|Hvidovre, Denmark, 2650|
|Principal Investigator:||Nina Kimer, MD||Department of Gastroenterology, Cpenhagen University Hospital Hvidovre|