Loading clinical trials...

Efficacy and Tolerability of Lubiprostone in Patients With Nonalcoholic Fatty Liver Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT05768334•Helwan University

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

November 1, 2020

Primary Completion Date

February 1, 2023

Completion Date

February 1, 2023

Last Updated

December 13, 2023

Enrollment

116

ACTUAL participants

Conditions

NAFLD

Interventions

Lubiprostone 24Mcg Oral twice daily

DRUG

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)

NCT06599918

Fatty LiverObesity+4 more

View study

RECRUITINGNA

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

NCT06218589

Metabolic Dysfunction Associated Steatotic Liver DiseaseNon-Alcoholic Fatty Liver Disease (NAFLD)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients

OneSTOP (One-Stop Telehealth Obesity Program) for Multidisciplinary Weight Management and Related Comorbidities

Prevalence of Non-Alcoholic Fatty Liver Disease in Inflammatory Bowel Disease Patients

Effects of Tomato Consumption on Steatosis, Intestinal Function and Glucose and Lipid Metabolism in Subjects With NAFLD