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

Primary Purpose

Hepatic Encephalopathy, Liver Cirrhosis, End Stage Liver DIsease

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

E.coli Nissle 1917

Lactulose

Rifaximin

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring hepatic encephalopathy, Liver Cirrhosis, End Stage Liver DIsease, E.coli Nissle 1917, Probiotic, lactulose, rifaximin

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

E.coli Nissle 1917

Lactulose

Rifaximin

Arm Description

probiotic, oral, for the first 4 days, 1 capsule, and then 2 capsules per day for 1 month treatment

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, oral, 500 mg BID, 1 months of treatment

Outcomes

Primary Outcome Measures

Change in Stroop test

Change in serum ammonia

Secondary Outcome Measures

Change in serum inflammatory cytokine

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

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)

Full Information

NCT ID

NCT04787276

First Posted

March 2, 2021

Last Updated

March 5, 2021

Sponsor

Bogomolets National Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04787276

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 10, 2017 (Actual)

Primary Completion Date

January 15, 2020 (Actual)

Study Completion Date

March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bogomolets National Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatic Encephalopathy, Liver Cirrhosis, End Stage Liver DIsease

Keywords

hepatic encephalopathy, Liver Cirrhosis, End Stage Liver DIsease, E.coli Nissle 1917, Probiotic, lactulose, rifaximin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

E.coli Nissle 1917

Arm Type

Experimental

Arm Description

probiotic, oral, for the first 4 days, 1 capsule, and then 2 capsules per day for 1 month treatment

Arm Title

Lactulose

Arm Type

Active Comparator

Arm Description

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

Arm Title

Rifaximin

Arm Type

Active Comparator

Arm Description

rifaximin, oral, 500 mg BID, 1 months of treatment

Intervention Type

Dietary Supplement

Intervention Name(s)

E.coli Nissle 1917

Other Intervention Name(s)

MUTAFLOR capsules

Intervention Description

Probiotic contains biomass of E.coli Nissle 1917, 2,5-25·109 colony forming units - CFU/g

Intervention Type

Drug

Intervention Name(s)

Lactulose

Other Intervention Name(s)

DUPHALAC

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rifaximin

Other Intervention Name(s)

Alfa Normix

Intervention Description

rifaximin, oral, 500 mg BID, 1 months of treatment

Primary Outcome Measure Information:

Title

Change in Stroop test

Time Frame

1 month

Title

Change in serum ammonia

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Change in serum inflammatory cytokine

Description

The level of IL-6, IL-8 and INFγ in pg / ml will be assesed

Time Frame

1 month

Title

Bacteriology measured in the stool flora by specialized non-culture techniques

Description

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elina Manzhalii, PhD

Organizational Affiliation

Bogomolets National Medical University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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