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

Bogomolets National Medical University

Status: Completed

Conditions: Hepatic Encephalopathy; Liver Cirrhosis; End Stage Liver DIsease

Treatments: Drug: Rifaximin; Dietary Supplement: E.coli Nissle 1917; Drug: Lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT04787276

HepEN

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

E.coli Nissle 1917

Experimental group

Description:

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

Treatment:

Dietary Supplement: E.coli Nissle 1917

Lactulose

Active Comparator group

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

Treatment:

Drug: Lactulose

Rifaximin

Active Comparator group

Description:

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

Treatment:

Drug: Rifaximin