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

Liver Cirrhosis Clinical Trial

Official title:

Probiotic E.Coli Nissle 1917 Comparing to Lactulose and Rifaximin in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04787276
• Other study ID #: HepEN
• Status: Completed
• Phase: N/A
• Start date: January 10, 2017
• Est. completion date: March 15, 2020

Study information

• Verified date: March 2021
• Source: Bogomolets National Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 15, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Diseases
• End Stage Liver Disease
• Fibrosis
• Hepatic Encephalopathy
• Liver Cirrhosis
• Liver Diseases

Intervention

Dietary Supplement:
• E.coli Nissle 1917
Probiotic contains biomass of E.coli Nissle 1917, 2,5-25?109 colony forming units - CFU/g

Drug:
• 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
• Rifaximin
rifaximin, oral, 500 mg BID, 1 months of treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bogomolets National Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Stroop test		1 month
Primary	Change in serum ammonia		1 month
Secondary	Change in serum inflammatory cytokine	The level of IL-6, IL-8 and INF? in pg / ml will be assesed	1 month
Secondary	Bacteriology measured in the stool flora by specialized non-culture techniques	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)	1 month