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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-10

Study Completion Date

2020-03-15

Brief Summary

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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

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Detailed Description

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Conditions

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Hepatic Encephalopathy Liver Cirrhosis End Stage Liver DIsease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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E.coli Nissle 1917

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

Group Type EXPERIMENTAL

E.coli Nissle 1917

Intervention Type DIETARY_SUPPLEMENT

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

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

Group Type ACTIVE_COMPARATOR

Lactulose

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

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

Interventions

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E.coli Nissle 1917

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DRUG

Rifaximin

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

Intervention Type DRUG

Other Intervention Names

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MUTAFLOR capsules DUPHALAC Alfa Normix

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No