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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E.coli Nissle 1917 | Experimental | probiotic, oral, for the first 4 days, 1 capsule, and then 2 capsules per day for 1 month treatment |
|
| 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 |
|
| Rifaximin | Active Comparator | rifaximin, oral, 500 mg BID, 1 months of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E.coli Nissle 1917 | Dietary Supplement | Probiotic contains biomass of E.coli Nissle 1917, 2,5-25·109 colony forming units - CFU/g |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stroop test | 1 month | |
| Change in serum ammonia | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum inflammatory cytokine | The level of IL-6, IL-8 and INFγ in pg / ml will be assesed | 1 month |
| Bacteriology measured in the stool flora by specialized non-culture techniques | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elina Manzhalii, PhD | Bogomolets National Medical University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37467180 | Derived | 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. |
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| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D008103 | Liver Cirrhosis |
| D058625 | End Stage Liver Disease |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| D000078262 | Rifaximin |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| 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 |
|
|
| Rifaximin | Drug | rifaximin, oral, 500 mg BID, 1 months of treatment |
|
|
| 1 month |
| D001928 |
| Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073893 |
| Sugars |
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |