Detection of Helicopacter Pylori in Patients With Metabolic Associated Fatty Liver Disease

NCT ID: NCT07128147

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-09-01
• Study Completion Date: 2027-09-01

Brief Summary

Owing to the correlation between H.pylori and MAFLD, our study aims to search for H.pylori in every patient with MAFLD to aid in the management of MAFLD and improve quality of life for these patients by decreaseing morbidity and mortality.

Detailed Description

Non-alcoholic fatty liver disease (NAFLD) has become increasingly common in recent years. NAFLD is considered the primary cause of chronic liver disorders and has emerged as a significant global public health concern.

The prevalence of NAFLD has been steadily rising due to changes in lifestyle and dietary habits, making it the most common chronic liver disease worldwide. The global prevalence of NAFLD is estimated at 30.1%.

Recently, researchers published an international expert consensus statement introducing a new definition: metabolic dysfunction-associated fatty liver disease (MAFLD), intended to replace the term non-alcoholic fatty liver disease (NAFLD).

The new nomenclature, MAFLD, is based on the presence of steatosis in more than 5% of hepatocytes, along with the absence of excessive alcohol consumption or other causes of chronic liver disease. A diagnosis of MAFLD can be established by the presence of hepatic steatosis in combination with one of the following three criteria: overweight/obesity, type 2 diabetes mellitus, or evidence of metabolic dysregulation.

Metabolic dysregulation is defined as having at least two of the following metabolic risk abnormalities: increased waist circumference, elevated blood pressure, dyslipidemia, prediabetes, insulin resistance, or elevated plasma C-reactive protein levels.

One potential hidden cause of cryptogenic cirrhosis is "burned-out" NAFLD. Therefore, early treatment of NAFLD and its underlying risk factors is crucial to prevent liver damage and potential liver failure.

Research has shown that abnormal lipid metabolism in the liver can lead to dysbiosis of the intestinal flora. This imbalance can further promote lipid accumulation in the liver. Additionally, NAFLD has been associated with gut microbiota alterations, particularly involving Helicobacter pylori (H. pylori).

Globally, infection with H. pylori affects approximately 50% or more of the population. H. pylori is a gram-negative bacterium that colonizes the human stomach and is known for its role in various gastrointestinal diseases. It is a major etiological factor in chronic peptic ulcer disease, which includes both gastric and duodenal ulcers.

The bacterium's ability to survive in the stomach's acidic environment is facilitated by its production of urease, an enzyme that neutralizes stomach acid. Chronic H. pylori infection can result in complications such as peptic ulcers, gastritis, and chronic indigestion (dyspepsia), making it a significant global public health issue. It may also lead to serious conditions like gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma.

Furthermore, some researchers have found a connection between H. pylori and liver cancer, diabetes, and disrupted lipid metabolism.

Several studies have indicated that H. pylori infection is one of the contributing factors in the progression of NAFLD and that eradication of H. pylori may partially halt the development of the disease.

Conditions

Helicobacter Pylori Infection Metabolic Dysfunction-Associated Fatty Liver Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• All patients aged >18 years old.
• Was diagnosed as MAFLD based on abdominal ultrasonography (US) or other imaging techniques.

Exclusion Criteria

• Patients aged ≤18 years old.
• Pregnancy.
• Presence of malignancy.
• Type I DM.
• Patients with fatty liver who undergone bariatric surgeries.
• Previous history of alcohol consumption, steroids, proton pump inhibitors, antibiotics, and contraceptive pills.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amira Mohammed Abdel Mowgod

Lecturer, Tropical Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amira M Assiut University, Lecturer, MD, Trop Med

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Amira M Abdelmawgod, Lecturer, MD, Trop Med

Role: CONTACT

amiramohmad60@gmail.com

+201012760437

Other Identifiers

4-2025-300645

Identifier Type: -

Identifier Source: org_study_id