Status:

UNKNOWN

Potential Benefits of Itopride in the Management of Patients With Metabolic Associated Fatty Liver Disease (MAFLD)

Lead Sponsor:

October 6 University

Collaborating Sponsors:

Beni-Suef University

Conditions:

Fatty Liver Disease

Fatty Liver

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

Brief Summary

Objective of this study is to determine the clinical benefits of itopride in improvement of MAFLD

Detailed Description

the study will evaluate the possible benefits of itopride when added to pateints with metabolic associated fatty liver disease

Eligibility Criteria

Inclusion

  • Patients presented to hepatology clinic . -Patients are diagnosed by ultrasonography and laboratory tests for liver and lipids. - -
  • Patients with comorbidites like hypertension,diabetes,dyslipidemia

Exclusion

  • Exclusion criteria included the presence of liver disease due to any of the following: viral hepatitis (HBV, HCV)
  • acute systemic disease
  • cystic fibrosis, coeliac disease
  • suspicion of muscular dystrophy, alpha-1-antitrypsin deficiency
  • metabolic inherited diseases
  • autoimmune hepatitis, drug toxicity and drugs known to induce steatosis (e.g. valproate, amiodarone orprednisone).
  • Patients were also excluded if body weight and carbohydrate metabolism were altered by the use of parenteral nutrition
  • protein malnutrition
  • previous gastrointestinal surgery
  • structural abnormalitiesof the gastrointestinal tract or neurological impairment.
  • the use of nonsteroidal anti-inflammatory drugs,antibiotics,sglt2,dpp4,statins,glp1
  • probiotics or anti-secretory drugs capable of causing achlorhydria within 2 months preceding enrolmentwere also considered exclusion criteria.
  • Patient with age below 18 or above 60

Key Trial Info

Start Date :

December 28 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05966025

Start Date

December 28 2023

End Date

December 1 2025

Last Update

October 31 2023

Active Locations (1)

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1

Maha Youssif Fekry

Giza, Egypt, 12573