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

Helwan University116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

116

Conditions

NAFLD

Interventions

Lubiprostone 24Mcg Oral twice dailyDRUG

The patients will be randomized (closed envelopes) into one of two groups: 1. Fifty patients will receive lubiprostone 24 mcg (microgram) twice daily. 2. Fifty patients will receive placebo twice daily (control group). All patients will be followed for 48 weeks.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Hepatology and Tropical Medicine Research Institute

Cairo, Egypt

Outcomes

Primary Outcomes

MRI-PDFF (the magnetic resonance imaging-estimated proton density fat fraction).

change in fat quantification

Time frame: 48 weeks

Secondary Outcomes

FibroScan with CAP (Controlled Attenuation Parameter)

change in fat quantification

Time frame: 48 weeks

Data from ClinicalTrials.gov

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