Non-alcoholic Fatty Liver DiseaseNCT02884037
Rifaximin Modify the Pathogenesis of Non-Alcoholic Fatty Liver Disease (NAFLD)
An observational study of Non-alcoholic Fatty Liver Disease, run by Mansoura University at 1 site in Egypt.
Trial summary
In this multicentric, double-blind, randomized,placebo-controlled study, the investigators hypothesized that rifaximin might act on Gram-negative bacteria and intestinal bacterial overgrowth(IBO) thereby inhibiting lipopolysaccharides(LPS)-mediated proinflammatory cytokine production. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Rifaximin group 1
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- May 2012to Oct 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this multicentric, double-blind, randomized,placebo-controlled study, we enrolled consecutively 1072 participants with hepatitis irrespective to their etiologies referred to the Tropical Medicine and Internal Medicine Departments (Mansoura University), Tropical Medicine Department (Zagazig University), and Internal Medicine and Endemic Diseases and Gastroenterology Departments (Aswan University)from May 2012 to October 2016. All participants underwent to the following appraisal: physical and biochemical examination, complete history taking, abdominal ultrasound, and percutaneous ultrasound liver biopsy.
Who may be able to join
- women or men aged 18-65 years.
- biopsy-proven NASH without or with mild to moderate fibrosis (fibrosis stage 0-3)in the preceding year.
- persistently abnormal ALT on 2 occasions.
- participants have provided written informed consent before screening.
- all patients counseled about the standard of care treatment (e.g., diet andexercise).
- Strict requirements for weight stability between the time of biopsy and study entry.
Who cannot join
- Cirrhotic NAFLD (METAVIR stage 4).
- Combined viral hepatitis B and C infection.
- increased alcohol intake (>20 g/day) and hypothyroidism.
- co-existence of another type of biliary tract or pancreatic or liver diseases
- lactating or pregnant women.
- allergy to rifamycin or rifaximin.
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- systemic inflammatory conditions (e.g. Connective tissue diseases and inflammatory bowel diseases).
- bariatric surgery and blind loop.
- evidence of hepatic decompensation (ascites, hepatic encephalopathy, and varices),
- history of myocardial infarction and/ or stroke within 6 months.
- drugs that alter the gut flora e.g. Lactulose, systemic antibiotic, cholestyramine within three months, (l) cancers especially HCC, and (m)patients with renal impairment (estimated GFR <60ml/min/1.73m2).
- Major dose change orintiation of biguanides, metformin, thiazolidinediones, insulin, fibrates, statins, and anti-obesity medications within three months before the onset of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Could Rifaximin Modify the Pathogenesis of NAFLD? AMulticenter, Randomized, Double-Blind, Placebo-Controlled Trial
In this multicentric, double-blind, randomized,placebo-controlled study, the investigators hypothesized that rifaximin might act on Gram-negative bacteria and intestinal bacterial overgrowth(IBO) thereby inhibiting lipopolysaccharides(LPS)-mediated proinflammatory cytokine production. This work evaluates the efficacy of 6 months administration of rifaximin in NAFLD patients.
Read the detailed description
The investigators aimed to study the effect of rifaximin on NASH. 50 patients with biopsy-proven NASH were enrolled in this double-blind, randomized,placebo-controlled study. BMI, AST, ALT, gamma glutamyl transferase (γ-GGT), lipid profile, homeostatic model assessment (HOMA), serum endotoxin, Toll-like receptor 4 (TlR4), interleukin-6 (IL-6), IL-10, tumor necrosis factor-α (TNF-α) and cytokeratin-18 (CK-18) levels were measured before and after a 6 month administration of rifaximin (1100mg/day, 550 mg tablets 1 × 2 before meals).
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Rifaximin group 1
- Keywords
- NAFLD, Rifaximin, Endotoxin and Homeostatic Model Assessment
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin group 1Drug
Rifaximin: 1100mg/day, 550 mg tablets 1 × 2 before meals
| Study group | Role | What they receive |
|---|---|---|
| 1 | Rifaxmin group Receives: Drug: Rifaximin group 1 | |
| 2 | placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum ALT
U/l
Measured: 6 months
serum endotoxins
EU/ml
Measured: 6 months
TLR-4
ng/ml
Measured: 6 months
Secondary outcomes (3)
Fasting Glucose
mg/dl
Measured: 6 months
, Insulin,
μIU/ml
Measured: 6 months
CK-18,TNF-α, IL-6, IL 10
pg/ml
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasser Mousa, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884037
- Sponsor's protocol ID
- R/16.02.80
- Status last verified
- Aug 2017
- First submitted
- 29 Jul 2016
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could Rifaximin Modify the Pathogenesis of NAFLD? AMulticenter, Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT02884037
- Acronym / sponsor ID
- R/16.02.80
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- NAFLD, Rifaximin, Endotoxin and Homeostatic Model Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Aug 2016 (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.
In this multicentric, double-blind, randomized,placebo-controlled study, the investigators hypothesized that rifaximin might act on Gram-negative bacteria and intestinal bacterial overgrowth(IBO) thereby inhibiting lipopolysaccharides(LPS)-mediated proinflammatory cytokine production. This work evaluates the efficacy of 6 months administration of rifaximin in NAFLD patients.
Detailed description
The investigators aimed to study the effect of rifaximin on NASH. 50 patients with biopsy-proven NASH were enrolled in this double-blind, randomized,placebo-controlled study. BMI, AST, ALT, gamma glutamyl transferase (γ-GGT), lipid profile, homeostatic model assessment (HOMA), serum endotoxin, Toll-like receptor 4 (TlR4), interleukin-6 (IL-6), IL-10, tumor necrosis factor-α (TNF-α) and cytokeratin-18 (CK-18) levels were measured before and after a 6 month administration of rifaximin (1100mg/day, 550 mg tablets 1 × 2 before meals).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Rifaximin group 1Rifaxmin group |
| 2 | – | –placebo group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this multicentric, double-blind, randomized,placebo-controlled study, we enrolled consecutively 1072 participants with hepatitis irrespective to their etiologies referred to the Tropical Medicine and Internal Medicine Departments (Mansoura University), Tropical Medicine Department (Zagazig University), and Internal Medicine and Endemic Diseases and Gastroenterology Departments (Aswan University)from May 2012 to October 2016. All participants underwent to the following appraisal: physical and biochemical examination, complete history taking, abdominal ultrasound, and percutaneous ultrasound liver biopsy.
Key inclusion criteria (6 listed)
- women or men aged 18-65 years.
- biopsy-proven NASH without or with mild to moderate fibrosis (fibrosis stage 0-3)in the preceding year.
- persistently abnormal ALT on 2 occasions.
- participants have provided written informed consent before screening.
- all patients counseled about the standard of care treatment (e.g., diet andexercise).
Key exclusion criteria (12 listed)
- Cirrhotic NAFLD (METAVIR stage 4).
- Combined viral hepatitis B and C infection.
- increased alcohol intake (>20 g/day) and hypothyroidism.
- co-existence of another type of biliary tract or pancreatic or liver diseases
- lactating or pregnant women.
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 |
|---|---|---|
| Rifaximin group 1Rifaximin: 1100mg/day, 550 mg tablets 1 × 2 before meals | Drug | 1 |
Primary outcome
serum ALT
Time frame: 6 months
U/l
serum endotoxins
Time frame: 6 months
EU/ml
TLR-4
Time frame: 6 months
ng/ml
3 secondary outcomes
Fasting Glucose
Time frame: 6 months
, Insulin,
Time frame: 6 months
CK-18,TNF-α, IL-6, IL 10
Time frame: 6 months
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 11 Aug 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-alcoholic Fatty Liver Disease, run by Mansoura University at 1 site in Egypt.
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 6 inclusion and 12 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 11 Aug 2017. 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 Egypt. 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?
serum ALT (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2017; AzTrials last refreshed its copy on 8 Nov 2026.