K72.7
Conditions
Interventions
Group 1: Rifaximin 550mg 1-0-1 per os for 90 days
Group 2: 550mg rifaximin bid 1-0-1 po for 90 days in combination with lactulose three to four times 7,5 - 15 ml up to 30-60 ml daily (to pass 2-3 semi
Sponsors
Medizinische Fakultät der Otto-von-Guericke Universität
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Male and female individuals 18 - 90 years of age at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry; 2. Individuals with a projected life expectancy of 6 months or longer; 3. Individuals who are able to comply with all study procedures and requirements; 4. Female subjects with childbearing potential who have negative pregnancy test during screening period. 5. diagnosis of liver cirrhosis, established either by histology or by typical signs in transabdominal ultrasound in combination with signs of portal hypertension (ascites, enlarged spleen, fundic or esophageal varices) 6. presence of minimal hepatic encephalopathy (MHE)
Exclusion criteria
Exclusion criteria: Individuals with one of the following medical conditions: 1. Documented underlying allergic condition against rifaximin or lactulose 2. Underlying blindness or eye axis deviation or red- green- color- blindness 3. Individuals with a projected life expectancy of less than 6 months 4. overt hepatic encephalopathy 5. antibiotic treatment within 28 days before study entry or during the study 6. Individuals who are not in sufficient health status as determined by the outcome of medical history, physical assessment, and clinical judgment of the investigator. 7. Individuals who are not able to follow the required study procedures for the whole period of the study. 8. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject´s ability to participate in the trial. 9. Individuals who are planned to be hospitalized or undergo surgery during the study period. 10. Individuals who have participated in another clinical study within 30 days prior enrollment into the study. 11. Individuals with ongoing drug- or alcohol abuse that, in the opinion of the investigator, would interfere with the safety of the subject or the evaluation of the study objectives. 12. Individuals who are member of the research staff or have relatives who are member of the research staff. 13. Female subjects with childbearing potential who have positive pregnancy test during screening period. Female subjects no use of common contraceptive methods. Pregnant and lactating women. 14. Individuals with a medical history or any illness that may, in the opinion of the investigator, pose additional risk to the subject due to participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy variable: neurocognitive function measured in CFF( Critical Flicker Test), NCT(Number Cancellation Test),VEP (Visually Evoked Potentials) Treatment Phase (EOT): Screening, Visit1 after 30 days +/-3 days, Visit 2 after 60 days +/-3 days, Visit 3 after 90 days +/-3 days, Follow up after 120 days: Visit 5 6 weeks after end of Treatment (EOT) Visit 6 12 weeks after end of Treatment (EOT) = end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy variable: - EEG, quality of life and Health-Related Quality of Life (ECOG performance status and HR-QOL - EORTC QLQ C30)- changes in gut microbiome - influence of infection with H. pylori Visite:4 120 Tagen after end of Treatment (EOT) | — |
Countries
Germany
Contacts
Public ContactChristian Schulz
Medizinische Fakultät der Otto-von-Guericke-Universität, Klinik für Gastroenterologie, Hepatologie und Infektiologie
Outcome results
None listed