Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease

Study Overview
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Brief Summary
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Objectives To evaluate the efficacy, safety, and tolerability of lubiprostone in patients with nonalcoholic fatty liver disease (NAFLD). This study will include 100 patients with nonalcoholic fatty liver disease (NAFLD) recruited from the specialized NAFLD outpatient's clinic in National Hepatology and Tropical Medicine Research Institute (NHTMRI). Study design: Randomized controlled trial.

Official Title
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Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease

Conditions
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NAFLD

Intervention / Treatment
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* Drug: Lubiprostone 24Mcg Oral twice daily


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 1. Age from 18-65 years. 2. Cases with NAFLD suspected by abdominal ultrasound or CT. 3. Negative viral hepatitis markers (Hepatitis B surface Antigen &Hepatitis C virus Antibody). 4. Negative autoantibodies (Antinuclear Antibody). 6. Non-cirrhotic patients as diagnosed by fibroScan (F4<14.6KPa). 7. Hepatic steatosis > 5% with MRI-PDFF. Exclusion Criteria: 1. History of other forms of liver disease (including viral hepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, and alpha-1-antitrypsin disease). 2. Alcohol intake exceeding 30 g/day in the last 10 years or exceeding 10 g/day in the previous year (Saunders et al., 1993). 3. Child-Pugh score > 7. 4. Cirrhotic patients diagnosed by fibroScan (F4>14.6KPa) 5. Calculated Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m2. 6. Pregnancy. 7. Evidence of hepatocellular carcinoma as stated by Barcelona Clinic Liver Cancer (BCLC) (Llovet et al., 2003). 8. Contraindications to MRI: prostetic heart valves and annuloplasty rings, metallic implants, patients who have peacemaker, and contrast allergy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lubiprostone<br>50 patients | Drug: Lubiprostone 24Mcg Oral twice daily<br>* The patients will be randomized (closed envelopes) into one of two groups: Fifty patients will receive lubiprostone 24 mcg (microgram) twice daily. Fifty patients will receive placebo twice daily (control group). All patients will be followed for 48 weeks.<br>|
| Placebo Comparator: Control arm<br>50 patients | Drug: Lubiprostone 24Mcg Oral twice daily<br>* The patients will be randomized (closed envelopes) into one of two groups: Fifty patients will receive lubiprostone 24 mcg (microgram) twice daily. Fifty patients will receive placebo twice daily (control group). All patients will be followed for 48 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction). | change in fat quantification | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FibroScan with CAP (Controlled Attenuation Parameter) | change in fat quantification | 48 weeks |