NCT04787276

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Bogomolets National Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-10
• Primary completion: 2020-01-15
• Completion: 2020-03-15
• First posted: 2021-03-08
• Last updated: 2021-03-08