Heart failure
Conditions
Interventions
Trade Name: Xifaxan
Product Name: Xifaxan
Pharmaceutical Form: Coated tablet
Trade Name: Precosa
Product Name: Precosa
Product Code: Precosa
Pharmaceutical Form: Capsule
Sponsors
Oslo University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 18 = and =65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Treatment with antibiotics or probiotics within the last 12 weeks • History of hypersensitivity to Rifaximin or other Rifamycin derived antimicrobial agents, or any of the components of Xifaxan (http://www.legemiddelverket.no/_layouts/Preparatomtaler/Spc/11- 8645.pdf?id=05122013165930). • History of hypersensitivity to S. boulardii, yeast, or any of the components of Precosa (http://www.legemiddelverket.no/_layouts/Preparatomtaler/Spc/1994 -02012.pdf?id=03042014142345). • Polypharmacia with increased risk for interactions. i.e. patient with an extensive medication lists (e.g. 10 drugs or more) which may influence with the patient safety or compromise the study results • Malignancy of any cause, excluding basal cell carcinoma of the skin • Acute coronary syndrome over the last 12 weeks • Severly impaired kidney function (i.e., estimated glomerulus filtration rate 150 U/l) or decompensated liver cirrhosis classified as Child–Pugh B or C. • On-going infection, including GI infection • Inflammatory bowel disease • Bowel obstruction • Active myocarditis, including Chagas disease • Severe primary valvular heart disease • Atrial fibrillation with ventricular frequency > 100/min • Any other, severe comorbid disease that must be expected to severely reduce the efficacy of the interventional products, survival or compliance • Treatment with immunosuppressive drugs • Treatment with rifamycins other than Rifaximin • Central venous catheter • Pregnancy or planned pregnancy • Nursing • Poor compliance • Any reason why, in the opinion of the investigator, the patient should not participate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: N/A;Timepoint(s) of evaluation of this end point: Baseline and after 3 months intervention;Main Objective: The main objective of the study is to investigate the gut microbiota as a potential therapeutic target in HF: • By characterizing the composition of gut microbiota in HF patients compared to healthy controls. • By characterizing the effect of antibiotics and probiotics on the gut microbiota and systemic inflammatory and metabolic markers in HF patients. • By characterizing the effect of antibiotics and probiotics on cardiac function in HF patients.;Primary end point(s): The primary end point of this study is baseline-adjusted LVEF as measured by echocardiography after 3 months of intervention.The trial is powered to show a 5 per cent point increase in either intervention arm compared to the control group (the statistical null-hypothesis being that there is no difference between any of the two intervention arms and the control arm). | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Baseline and after 3 months intervention;Secondary end point(s): The secondary endpoints will assess differences between either of the treatment arms an the control group at the end-of study, as well as at the pre-defined follow-up time points, regarding (i) the gut microbiota composition, (ii) microbiota-related metabolites, (iii) extended parameters on cardiac function in addition to LVEF, (iv) inflammatory and anti-inflammatory mediators in plasma, serum, peripheral blood mononuclear cells (PBMC) and whole blood, (v) health-related quality of life, (vi) functional capacity and (vii) safety | — |
Countries
Brazil, Norway
Contacts
Public ContactLars Gullestad
Oslo University Hospital
Outcome results
None listed