Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy

• Status: Completed
• Trial end date: 2020-03-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bogomolets National Medical University
• Treatments: Lactulose; Rifaximin

Criteria

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.