Hepatic EncephalopathyNCT04787276
Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy
A study testing E.coli Nissle 1917, Lactulose and Rifaximin in people with Hepatic Encephalopathy and Liver Cirrhosis, run by Bogomolets National Medical University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatic Encephalopathy, Liver Cirrhosis, End Stage Liver DIsease
- What is being tested?
- E.coli Nissle 1917, Lactulose and Rifaximin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2017to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
Official title: Probiotic E.Coli Nissle 1917 Comparing to Lactulose and Rifaximin in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy
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
- Being tested
- E.coli Nissle 1917, Lactulose, Rifaximin
- Keywords
- hepatic encephalopathy, Liver Cirrhosis, End Stage Liver DIsease, E.coli Nissle 1917, Probiotic, lactulose, rifaximin
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E.coli Nissle 1917Dietary supplement
Also called MUTAFLOR capsules
Probiotic contains biomass of E.coli Nissle 1917, 2,5-25·109 colony forming units - CFU/g
LactuloseDrug
Also called DUPHALAC
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
RifaximinDrug
Also called Alfa Normix
rifaximin, oral, 500 mg BID, 1 months of treatment
| Study group | Role | What they receive |
|---|---|---|
| E.coli Nissle 1917 | Experimental | probiotic, oral, for the first 4 days, 1 capsule, and then 2 capsules per day for 1 month treatment Receives: 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 Receives: Drug: Lactulose |
| Rifaximin | Active comparator | rifaximin, oral, 500 mg BID, 1 months of treatment Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Stroop test
Measured: 1 month
Change in serum ammonia
Measured: 1 month
Secondary outcomes (2)
Change in serum inflammatory cytokine
The level of IL-6, IL-8 and INFγ in pg / ml will be assesed
Measured: 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)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start10 Jan 2017
- Primary completion15 Jan 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bogomolets National Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazarii Kobyliak, Bogomolets National Medical University
- Investigators
- Elina Manzhalii, PhD, Principal investigator, Bogomolets National Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787276
- Sponsor's protocol ID
- HepEN
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37467180
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic E.Coli Nissle 1917 Comparing to Lactulose and Rifaximin in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT04787276
- Acronym / sponsor ID
- HepEN
- Keywords
- hepatic encephalopathy, Liver Cirrhosis, End Stage Liver DIsease, E.coli Nissle 1917, Probiotic, lactulose, rifaximin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bogomolets National Medical UniversityUniversity, hospital or other
- Study start
- 10 Jan 2017 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| E.coli Nissle 1917 | Experimental | Dietary Supplement: E.coli Nissle 1917probiotic, oral, for the first 4 days, 1 capsule, and then 2 capsules per day for 1 month treatment |
| Lactulose | Active comparator | Drug: Lactulosewill 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 | Drug: Rifaximinrifaximin, oral, 500 mg BID, 1 months of treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E.coli Nissle 1917Also: MUTAFLOR capsulesProbiotic contains biomass of E.coli Nissle 1917, 2,5-25·109 colony forming units - CFU/g | Dietary supplement | E.coli Nissle 1917 |
| LactuloseAlso: DUPHALACwill 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 |
| RifaximinAlso: Alfa Normixrifaximin, oral, 500 mg BID, 1 months of treatment | Drug | Rifaximin |
Primary outcome
Change in Stroop test
Time frame: 1 month
Change in serum ammonia
Time frame: 1 month
2 secondary outcomes
Change in serum inflammatory cytokine
Time frame: 1 month
Bacteriology measured in the stool flora by specialized non-culture techniques
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Derived from this study: PubMed 37467180Zacharias 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elina Manzhalii, PhD principal investigator
Bogomolets National Medical University
Questions about this trial
What is this clinical trial studying?
A study testing E.coli Nissle 1917, Lactulose and Rifaximin in people with Hepatic Encephalopathy and Liver Cirrhosis, run by Bogomolets National Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Stroop test (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04787276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.