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

NCT04787276 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-03-08

No results posted yet for this study

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

Conditions

Interventions

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

DRUG

Rifaximin

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

Sponsors & Collaborators

  • Bogomolets National Medical University

    lead OTHER

Principal Investigators

  • Elina Manzhalii, PhD · Bogomolets National Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-10
Primary Completion
2020-01-15
Completion
2020-03-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04787276 on ClinicalTrials.gov