Non-alcoholic Fatty Liver DiseasePhase 2NCT01654549
Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis
A Phase 2 study testing H.pylori eradication in people with Non-alcoholic Fatty Liver Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in non-diabetic subjects with non-alcoholic fatty liver… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- H.pylori eradication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Apr 2012to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Dyspeptic patients with positive antibody to H.pylori and persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.
Who cannot join
- Alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), diabetes mellitus, heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum creatinine concentration of > 1.5 mg/dl), any severe systemic co-morbidities, neoplasm, using any medication during the past 3 months, previous history of peptic ulcer, previous history of H.pylori eradication, existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-diabetic Subjects With Non-alcoholic Fatty Liver Disease
The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in non-diabetic subjects with non-alcoholic fatty liver disease.
Read the detailed description
Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.
This randomized double blind clinical trial was performed in non-diabetic dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six weeks post-treatment.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- H.pylori eradication
- Keywords
- Steatohepatitis,, Helicobacter pylori,, Insulin resistance,, Alanine aminotransferase,, Aspartate aminotransferase,
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.pylori eradicationDrug
Also called H.pylori treatment
Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle modification | No intervention | Obtaining ideal body weight by calorie restriction diet and programmed physical activity |
| H.pylori eradication | Experimental | H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity Receives: Drug: H.pylori eradication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Fat Content
Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment).
The percent of liver fat was calculated as below:
"Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 1 / no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)"
Measured: 8 weeks (6 weeks post-treatment)
Secondary outcomes (6)
Serum Alanine Aminotransferase Level
Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study
Measured: 8 weeks
Serum Aspartate Aminotransferase Level
Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study
Measured: 8 weeks
Fasting Serum Glucose
Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study
Measured: 8 weeks
Serum Lipid Profile
Secondary outcome measure was change in serum lipid profile (including serum triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein concentration) from baseline to the end of study
Measured: 8 weeks
Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)
Secondary outcome measure was change in HOMA-IR from baseline to the end of study
Measured: 8 weeks
Anthropometric Measurements
Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raika Jamali, MD, Tehran University of Medical Sciences
- Investigators
- Raika Jamali, M.D., Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654549
- Sponsor's protocol ID
- 1391/3/27-573
- Status last verified
- Apr 2018
- First submitted
- 27 Jul 2012
- Last updated
- 28 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Helicobacter Pylori Eradication on Liver Fat Content in Non-diabetic Subjects With Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT01654549
- Acronym / sponsor ID
- 1391/3/27-573
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Steatohepatitis,, Helicobacter pylori,, Insulin resistance,, Alanine aminotransferase,, Aspartate aminotransferase,
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 21 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in non-diabetic subjects with non-alcoholic fatty liver disease.
Detailed description
Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.
This randomized double blind clinical trial was performed in non-diabetic dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six weeks post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle modification | No intervention | –Obtaining ideal body weight by calorie restriction diet and programmed physical activity |
| H.pylori eradication | Experimental | Drug: H.pylori eradicationH.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Dyspeptic patients with positive antibody to H.pylori and persistent elevated aminotransferase levels with the evidence of fatty liver in ultrasonography, who were referred to a gastroenterology clinic.
Key exclusion criteria (1 listed)
- Alcohol use (more than 20 gram per day in men and 10 gram per day in women per day), diabetes mellitus, heart disease (ischemic or congestive), hepatic disease (viral hepatitis, autoimmune hepatitis, wilson disease, hemochromatosis, liver mass lesion), renal disease (serum creatinine concentration of > 1.5 mg/dl), any severe systemic co-morbidities, neoplasm, using any medication during the past 3 months, previous history of peptic ulcer, previous history of H.pylori eradication, existence of alarm signs (weight loss, dysphagia, anemia, vomiting, positive family history of gastrointestinal cancers), and pregnant or lactating 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 |
|---|---|---|
| H.pylori eradicationAlso: H.pylori treatmentOmeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD) | Drug | H.pylori eradication |
Primary outcome
Liver Fat Content
Time frame: 8 weeks (6 weeks post-treatment)
Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment). The percent of liver fat was calculated as below: "Liver fat content (%) = 10 (-0.805 + 0.282 * metabolic syndrome (yes = 1 / no = 0) + 0.078 * type 2 diabetes (yes =2 / no =0) + 0.525 * log fasting serum insulin (mU/L) + 0.521 * log fasting serum AST (U/L) - 0.454 * log (AST/ALT)"
6 secondary outcomes
Serum Alanine Aminotransferase Level
Time frame: 8 weeks
Serum Aspartate Aminotransferase Level
Time frame: 8 weeks
Fasting Serum Glucose
Time frame: 8 weeks
Serum Lipid Profile
Time frame: 8 weeks
Homeostasis Model Assessment-Insulin Resistance (HOMA-IR)
Time frame: 8 weeks
Anthropometric Measurements
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Raika Jamali, M.D. principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing H.pylori eradication in people with Non-alcoholic Fatty Liver Disease, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 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 28 Jun 2018. 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 Iran. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Liver Fat Content (time frame: 8 weeks (6 weeks post-treatment)). 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 28 Jun 2018.