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

Not Applicable

Completed

• Conditions: Hepatic Encephalopathy; Liver Cirrhosis; End Stage Liver DIsease
• Interventions: Dietary Supplement: E.coli Nissle 1917; Drug: Rifaximin; Drug: Lactulose

• Registration Number: NCT04787276
• Lead Sponsor: Bogomolets National Medical University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-10
• Primary Completion: 2020-01-15
• Study Completion: 2020-03-15
• Status Verified: 2021-03
• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-05
• Last Update Submitted: 2021-03-05
• Study First Posted: 2021-03-08
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E.coli Nissle 1917	E.coli Nissle 1917	probiotic, oral, for the first 4 days, 1 capsule, and then 2 capsules per day for 1 month treatment
Rifaximin	Rifaximin	rifaximin, oral, 500 mg BID, 1 months of treatment
Lactulose	Lactulose	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

Primary Outcome Measures

Name	Time	Method
Change in Stroop test	1 month
Change in serum ammonia	1 month

Secondary Outcome Measures

Name	Time	Method
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)