Status:
COMPLETED
Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy
Lead Sponsor:
Bogomolets National Medical University
Conditions:
Hepatic Encephalopathy
Liver Cirrhosis
Eligibility:
All Genders
18-65 years
Phase:
NA
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 encep...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04787276
Start Date
January 10 2017
End Date
March 15 2020
Last Update
March 8 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.