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Completed

NCT Number: NCT04787276

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

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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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases End Stage Liver Disease Fibrosis Hepatic Insufficiency Liver Cirrhosis Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E.coli Nissle 1917

Dietary Supplement

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

Other names: MUTAFLOR capsules

Lactulose

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

Other names: DUPHALAC

Rifaximin

Drug

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

Other names: Alfa Normix

Primary outcomes

  1. Change in Stroop test

    Time frame: 1 month

  2. Change in serum ammonia

    Time frame: 1 month

Secondary outcomes

  1. Change in serum inflammatory cytokine

    Time frame: 1 month

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

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

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Bogomolets National Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 8, 2021
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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