End Stage Liver DIsease, Hepatic Encephalopathy, Liver Cirrhosis
Conditions
Keywords
hepatic encephalopathy, Liver Cirrhosis, End Stage Liver DIsease, E.coli Nissle 1917, Probiotic, lactulose, rifaximin
Brief summary
The purpose of study to assess the short-term efficacy and safety of probiotic E.coli Nissle 1917 strain comparing to lactulose and rifaximin in patients with mild (Stage 1-2) or minimal hepatic encephalopathy
Interventions
DIETARY_SUPPLEMENTE.coli Nissle 1917
Probiotic contains biomass of E.coli Nissle 1917, 2,5-25·109 colony forming units - CFU/g
DRUGLactulose
will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day, 1 months of treatment
DRUGRifaximin
rifaximin, oral, 500 mg BID, 1 months of treatment
Sponsors
Bogomolets National Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Cirrhosis diagnosed on the basis of liver biopsy, liver stiffness measurement or radiological study; * presence of minimal or mild (Grade 1-2) HE as defined by West Haven criteria; * two or more documented episodes of HE in the last 6 months, in addition to at least one episode in the last 3 months; * subject is capable and willing to comply with all study procedures; * signed inform consent.
Exclusion criteria
* history of taking L-ornithine- L -aspartate, zinc, metronidazole, or neomycin, antibiotics, probiotics and yogurt consumption within 6 weeks; * subject has a history of allergy or intolerance to lactulose and/or rifaximin; * alcohol intake during the past 6 month or during follow up; * recent (6 weeks) gastro-intestinal bleed; * hepato-cellular carcinoma or liver transplantation; * renal insufficiency; * significant comorbid illness such as heart or respiratory failure; * concurrent infection such as spontaneous bacterial peritonitis, pneumonia or urinary tract infection; * any neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies; * subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Stroop test | 1 month |
| Change in serum ammonia | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum inflammatory cytokine | 1 month | The level of IL-6, IL-8 and INFγ in pg / ml will be assesed |
| Bacteriology measured in the stool flora by specialized non-culture techniques | 1 month | The percentage of patients in each group were evaluated and characterized by a decrease below the normal content of symbiotic bacteria Bifidobacterium (less than 107 CFU / g), lactobacilli (less than 107 CFU / d), E.coli with normal properties (less than 106 CFU / d) and increase in content E.coli with altered properties (more than 106 CFU / g), pathogenic enterobacteria (not normally detected) and fungi of the genus Candida (more than 104 CFU / d) |
Outcome results
None listed