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

NCT04787276 | Completed

• 1 other identifier: HepEN
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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

Conditions

Hepatic Encephalopathy; Liver Cirrhosis; End Stage Liver DIsease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change in Stroop test

  1 month

• Change in serum ammonia

  1 month

Secondary Outcomes (2)

• Change in serum inflammatory cytokine

  1 month

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

  1 month

Study Arms (3)

E.coli Nissle 1917

EXPERIMENTAL

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

Dietary Supplement: E.coli Nissle 1917

Lactulose

ACTIVE COMPARATOR

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: Lactulose

Rifaximin

ACTIVE COMPARATOR

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

Drug: Rifaximin

Interventions

E.coli Nissle 1917 DIETARY_SUPPLEMENT

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

Also known as: MUTAFLOR capsules

E.coli Nissle 1917

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

Also known as: DUPHALAC

Lactulose

Rifaximin DRUG

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

Also known as: Alfa Normix

Rifaximin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bogomolets National Medical University: lead

Related Publications (1)

• Zacharias HD, Kamel F, Tan J, Kimer N, Gluud LL, Morgan MY. Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis. Cochrane Database Syst Rev. 2023 Jul 19;7(7):CD011585. doi: 10.1002/14651858.CD011585.pub2.

  PMID: 37467180 DERIVED

MeSH Terms

Conditions

Hepatic Encephalopathy; Liver Cirrhosis; End Stage Liver Disease

Interventions

Lactulose; Rifaximin

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Elina Manzhalii, PhD

  Bogomolets National Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Endocrinology Department

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 8, 2021
• Study Start: January 10, 2017
• Primary Completion: January 15, 2020
• Study Completion: March 15, 2020
• Last Updated: March 8, 2021

Record last verified: 2021-03