Phase 2
N=40
Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis
Non-alcoholic Fatty Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT01654549 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Liver Fat Content — 8.38; 7.72; 8.50; 7.29 percentage of liver fat content — p=0.94
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- H.pylori eradication (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tehran University of Medical Sciences
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liver Fat Content |
8.38; 7.72; 8.50; 7.29; 0.66; 1.21 | 0.94 |
| SECONDARY Serum Alanine Aminotransferase Level |
— | — |
| SECONDARY Serum Aspartate Aminotransferase Level |
— | — |
| SECONDARY Fasting Serum Glucose |
— | — |
| SECONDARY Serum Lipid Profile |
— | — |
| SECONDARY Homeostasis Model Assessment-Insulin Resistance (HOMA-IR) |
— | — |
| SECONDARY Anthropometric Measurements |
— | — |
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 disease.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01654549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.