Fatty LiverNCT02009592
Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients
A study testing Rifaximin in people with Fatty Liver and Steatohepatitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Non alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease, it encompasses from simple steatosis to non alcoholic steatohepatitis (NASH) and, eventually leads to cirrhosis and hepatocellular carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatty Liver, Steatohepatitis
- What is being tested?
- 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
- 1 siteTurkey (Türkiye)
- Study dates
- Jun 2013to Feb 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Allergy for Rifaximin, pregnant women and lactating women, other liver diseases such as viral hepatitis, autoimmune liver diseases, drug induced liver diseases, pancreas-biliary tract and liver-related documented diseases (pancreatitis, stone pouch on the biliary colic pains, acute cholecystitis, choledocholithiasis, hepatobiliary cancers etc.,). Hit-defined psychiatric illness, excessive alcohol intake (who consume >20g/day ) were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Antibiotic Rifaximin on the Lipopolysaccharides (LPS) and Related Cytokine Levels in Non Alcoholic Fatty Liver Disease Patients
Non alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease, it encompasses from simple steatosis to non alcoholic steatohepatitis (NASH) and, eventually leads to cirrhosis and hepatocellular carcinoma (HCC). Dysbiosis, over nutrition, life style, type 2 diabetes (T2DM) and metabolic syndrome are main causes in the disease progression. Research on the role of gut-liver axis in the pathogenesis of NAFLD has been slowly accumulating over the past few years. Endotoxemia resulting from intestinal bacterial overgrowth may contribute to the pathogenesis of NAFLD. So, intestinal microbiota (IM) serve as a potential therapeutic target in NASH. In this regard, we have aimed to test the efficacy of rifaximin against simple steatosis (NAFLD) and steatohepatitis (NASH) subjects in relation to serum endotoxins and related pro-inflammatory cytokine levels. We hypothesis that Rifaximin treatment may influence the endotoxin levels by modulating gut microbiota and partial alleviate from NAFLD/NASH.
Read the detailed description
Study area:
This prospective study conducted from July 2013 to March 2014 at Bezmialem Vakif University School of Medicine in the Department of Gastroenterology.
Subjects and methods:
Patients between the ages of 18-70, irrespective of gender referred to the gastroenterology clinics for persistently elevated liver enzymes, obesity, type 2 diabetes mellitus (T2DM) and clinical suspicion of NAFLD selected for this study. During the initial visit, patients are invited to participate in this study. After providing written informed consent, these patients received a detailed medical history, physical examination, Age, sex, BMI, waist circumference and appropriate laboratory tests will be made. Ultrasonography (US) examination takes place before biopsy.
Endotoxins and Pro-Inflammatory cytokine assays:
These assays are going to perform by using following ELISA kits. Tumour necrosis factor (TNF)-α, interleukin (IL)-1, IL-6, IL-10 and IL-12 obtained from EBIOSCİENCE company. LAL chromogenic end point assay kit obtained from HYCULT company and toll like receptor (TLR)-4 assay kit obtained from USCN company.
Statistical Analysis:
Statistical calculations 'Statistical Package for Social Sciences' (SPSS) software package for Windows 16 computer program was used. Descriptive statistics when numeric data as mean ± standard deviation, proportional data were used as the number and percentage rates. Independent samples t-test to compare the groups, and the chi-square and Mann-Whitney U tests were used for statistical analysis. P <0.05 will be considered as the limit of statistical significance.
- Conditions
- Fatty Liver, Steatohepatitis
- Being tested
- Rifaximin
- Keywords
- Hepatosteatosis, Steatohepatitis, Rifaximin, Inflammatory cytokines
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Colidur 200 mg tablets
Both arms receive Rifaximin
| Study group | Role | What they receive |
|---|---|---|
| Hepatosteatosis | Active comparator | Rifaximin was given to patients with hepatosteatosis in the doses of 3x2 daily, 200 mg tablets for 4 weeks. Receives: Drug: Rifaximin |
| Steatohepatitis | Active comparator | Rifaximin was given to patients with steatohepatitis patients in the doses of 3x2 daily, 200 mg tablets for 4 weeks. Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop in the levels of pro-inflammatory cytokines and increase in anti-inflammatory cytokines
Rifaximin treatment to both patient groups at the dose of 1200 mg/daily for 28 days. Blood samples obtain from all patients at 0 day, 14th day, 28th day and 60th day and collect serum for the analysis of the endotoxins and pro-inflammatory cytokines -TLR-4, TNF-α, IL-1 α, IL-6, IL-10 \& IL-12 levels.
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 posted12 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hakan Şenturk, Prof. Dr., Principal investigator, Director of the Gastroenterology unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009592
- Sponsor's protocol ID
- 18245212-108-99/164
- Status last verified
- May 2014
- First submitted
- 28 Nov 2013
- Last updated
- 16 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Day CP. Non-alcoholic fatty liver disease: current concepts and management strategies. Clin Med (Lond). 2006 Jan-Feb;6(1):19-25. doi: 10.7861/clinmedicine.6-1-19.
PubMed 16521351Kalambokis GN, Mouzaki A, Rodi M, Tsianos EV. Rifaximin improves thrombocytopenia in patients with alcoholic cirrhosis in association with reduction of endotoxaemia. Liver Int. 2012 Mar;32(3):467-75. doi: 10.1111/j.1478-3231.2011.02650.x. Epub 2011 Sep 26.
PubMed 22098272Vlachogiannakos J, Saveriadis AS, Viazis N, Theodoropoulos I, Foudoulis K, Manolakopoulos S, Raptis S, Karamanolis DG. Intestinal decontamination improves liver haemodynamics in patients with alcohol-related decompensated cirrhosis. Aliment Pharmacol Ther. 2009 May 1;29(9):992-9. doi: 10.1111/j.1365-2036.2009.03958.x. Epub 2009 Feb 7.
PubMed 19210289Diamant M, Blaak EE, de Vos WM. Do nutrient-gut-microbiota interactions play a role in human obesity, insulin resistance and type 2 diabetes? Obes Rev. 2011 Apr;12(4):272-81. doi: 10.1111/j.1467-789X.2010.00797.x. Epub 2010 Aug 26.
PubMed 20804522
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Antibiotic Rifaximin on the Lipopolysaccharides (LPS) and Related Cytokine Levels in Non Alcoholic Fatty Liver Disease Patients
- ClinicalTrials.gov ID
- NCT02009592
- Acronym / sponsor ID
- 18245212-108-99/164
- Conditions
- Fatty Liver, Steatohepatitis
- Keywords
- Hepatosteatosis, Steatohepatitis, Rifaximin, Inflammatory cytokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 12 Dec 2013 (estimated)
- 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.
Non alcoholic fatty liver disease (NAFLD) is a common cause of chronic liver disease, it encompasses from simple steatosis to non alcoholic steatohepatitis (NASH) and, eventually leads to cirrhosis and hepatocellular carcinoma (HCC). Dysbiosis, over nutrition, life style, type 2 diabetes (T2DM) and metabolic syndrome are main causes in the disease progression. Research on the role of gut-liver axis in the pathogenesis of NAFLD has been slowly accumulating over the past few years. Endotoxemia resulting from intestinal bacterial overgrowth may contribute to the pathogenesis of NAFLD. So, intestinal microbiota (IM) serve as a potential therapeutic target in NASH. In this regard, we have aimed to test the efficacy of rifaximin against simple steatosis (NAFLD) and steatohepatitis (NASH) subjects in relation to serum endotoxins and related pro-inflammatory cytokine levels. We hypothesis that Rifaximin treatment may influence the endotoxin levels by modulating gut microbiota and partial alleviate from NAFLD/NASH.
Detailed description
Study area:
This prospective study conducted from July 2013 to March 2014 at Bezmialem Vakif University School of Medicine in the Department of Gastroenterology.
Subjects and methods:
Patients between the ages of 18-70, irrespective of gender referred to the gastroenterology clinics for persistently elevated liver enzymes, obesity, type 2 diabetes mellitus (T2DM) and clinical suspicion of NAFLD selected for this study. During the initial visit, patients are invited to participate in this study. After providing written informed consent, these patients received a detailed medical history, physical examination, Age, sex, BMI, waist circumference and appropriate laboratory tests will be made. Ultrasonography (US) examination takes place before biopsy.
Endotoxins and Pro-Inflammatory cytokine assays:
These assays are going to perform by using following ELISA kits. Tumour necrosis factor (TNF)-α, interleukin (IL)-1, IL-6, IL-10 and IL-12 obtained from EBIOSCİENCE company. LAL chromogenic end point assay kit obtained from HYCULT company and toll like receptor (TLR)-4 assay kit obtained from USCN company.
Statistical Analysis:
Statistical calculations 'Statistical Package for Social Sciences' (SPSS) software package for Windows 16 computer program was used. Descriptive statistics when numeric data as mean ± standard deviation, proportional data were used as the number and percentage rates. Independent samples t-test to compare the groups, and the chi-square and Mann-Whitney U tests were used for statistical analysis. P <0.05 will be considered as the limit of statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hepatosteatosis | Active comparator | Drug: RifaximinRifaximin was given to patients with hepatosteatosis in the doses of 3x2 daily, 200 mg tablets for 4 weeks. |
| Steatohepatitis | Active comparator | Drug: RifaximinRifaximin was given to patients with steatohepatitis patients in the doses of 3x2 daily, 200 mg tablets for 4 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Allergy for Rifaximin, pregnant women and lactating women, other liver diseases such as viral hepatitis, autoimmune liver diseases, drug induced liver diseases, pancreas-biliary tract and liver-related documented diseases (pancreatitis, stone pouch on the biliary colic pains, acute cholecystitis, choledocholithiasis, hepatobiliary cancers etc.,). Hit-defined psychiatric illness, excessive alcohol intake (who consume >20g/day ) were excluded from this study.
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 |
|---|---|---|
| RifaximinAlso: Colidur 200 mg tabletsBoth arms receive Rifaximin | Drug | Hepatosteatosis, Steatohepatitis |
Primary outcome
Drop in the levels of pro-inflammatory cytokines and increase in anti-inflammatory cytokines
Time frame: 1 month
Rifaximin treatment to both patient groups at the dose of 1200 mg/daily for 28 days. Blood samples obtain from all patients at 0 day, 14th day, 28th day and 60th day and collect serum for the analysis of the endotoxins and pro-inflammatory cytokines -TLR-4, TNF-α, IL-1 α, IL-6, IL-10 \& IL-12 levels.
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 16 May 2014.
- Results publication: PubMed 16521351Day CP. Non-alcoholic fatty liver disease: current concepts and management strategies. Clin Med (Lond). 2006 Jan-Feb;6(1):19-25. doi: 10.7861/clinmedicine.6-1-19.
- Results publication: PubMed 22098272Kalambokis GN, Mouzaki A, Rodi M, Tsianos EV. Rifaximin improves thrombocytopenia in patients with alcoholic cirrhosis in association with reduction of endotoxaemia. Liver Int. 2012 Mar;32(3):467-75. doi: 10.1111/j.1478-3231.2011.02650.x. Epub 2011 Sep 26.
- Results publication: PubMed 19210289Vlachogiannakos J, Saveriadis AS, Viazis N, Theodoropoulos I, Foudoulis K, Manolakopoulos S, Raptis S, Karamanolis DG. Intestinal decontamination improves liver haemodynamics in patients with alcohol-related decompensated cirrhosis. Aliment Pharmacol Ther. 2009 May 1;29(9):992-9. doi: 10.1111/j.1365-2036.2009.03958.x. Epub 2009 Feb 7.
- Results publication: PubMed 20804522Diamant M, Blaak EE, de Vos WM. Do nutrient-gut-microbiota interactions play a role in human obesity, insulin resistance and type 2 diabetes? Obes Rev. 2011 Apr;12(4):272-81. doi: 10.1111/j.1467-789X.2010.00797.x. Epub 2010 Aug 26.
Related trials for Fatty Liver
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
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.
Hakan Şenturk, Prof. Dr. principal investigator
Director of the Gastroenterology unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rifaximin in people with Fatty Liver and Steatohepatitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 0 inclusion and 1 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Drop in the levels of pro-inflammatory cytokines and increase in anti-inflammatory cytokines (time frame: 1 month). 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 NCT02009592, which also lists 4 linked publications.
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 16 May 2014.