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

NCT ID: NCT05768334

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2023-02-01

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.

Detailed Description

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Conditions

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NAFLD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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lubiprostone

50 patients

Group Type ACTIVE_COMPARATOR

Lubiprostone 24Mcg Oral twice daily

Intervention Type DRUG

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.

Control arm

50 patients

Group Type PLACEBO_COMPARATOR

Lubiprostone 24Mcg Oral twice daily

Intervention Type DRUG

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.

Interventions

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Lubiprostone 24Mcg Oral twice daily

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.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helwan University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed El Kassas

Professor and chief of Endemic Medicine Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Hepatology and Tropical Medicine Research Institute

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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El-Kassas M, Mostafa H, Abdellatif W, Shoman S, Esmat G, Brahmania M, Liu H, Lee SS. Lubiprostone Reduces Fat Content on MRI-PDFF in Patients With MASLD: A 48-Week Randomised Controlled Trial. Aliment Pharmacol Ther. 2025 Feb;61(4):628-635. doi: 10.1111/apt.18478. Epub 2025 Jan 2.

Reference Type DERIVED
PMID: 39744921 (View on PubMed)

Other Identifiers

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11-2020

Identifier Type: -

Identifier Source: org_study_id