Helicobacter Pylori Infection Metabolic Dysfunction-Associated Fatty Liver DiseaseHpyloriMAFLDNCT07128147
Detection of Helicopacter Pylori in Patients With Metabolic Associated Fatty Liver Disease
An observational study of Helicobacter Pylori Infection Metabolic Dysfunction-Associated Fatty Liver Disease, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection Metabolic Dysfunction-Associated Fatty Liver Disease
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients, and their relatives, were invited to do screening for fatty liver by doing conventional abdominal ultrasound (US) by any member of the nutrition clinic team for assessment of liver echopattern.Patients with detected bright liver by US suggestive of fatty liver have undergone an evaluation for the BMI and tests to detect metabolic risk abnormalities.Diagnosis of MAFLD was made when a patient has BMI >25 kg/m2, T2DM or at least two metabolic risk abnormalities.Our study will use either H.pylori stool antigen test (SAT), after stoppage of PPI and antibiotics two weeks before the test, as it cheap and easy, or diagnostic upper endoscopy with biopsy.
Who may be able to join
- All patients aged >18 years old.
- Was diagnosed as MAFLD based on abdominal ultrasonography (US) or other imaging techniques.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Helicobacter pylori infection in patients with Metabolic Associated Fatty Liver Disease as determined by Urea Breath Test
- pylori infection will be assessed at baseline using a standardized H.pylori antigen in stool. Results will be reported as the proportion (%) of patients with a positive test among all enrolled participants
Measured: Baseline (Day 1 of hospital admission)
Prevalence of Helicobacter pylori Infection in Patients with MAFLD
Detection of H. pylori infection using [stool antigen test /endoscopic biopsy] in patients diagnosed with MAFLD
Measured: At baseline (hospital admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Oct 2026
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Infection Metabolic Dysfunction-Associated Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mohammed Abdel Mowgod, Assiut University
- Investigators
- Amira M Assiut University, Lecturer, MD, Trop Med, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128147
- Sponsor's protocol ID
- 4-2025-300645
- Acronym
- HpyloriMAFLD
- Status last verified
- Jul 2025
- First submitted
- 27 Jul 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Helicopacter Pylori in Patients With Metabolic Associated Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT07128147
- Acronym / sponsor ID
- HpyloriMAFLD / 4-2025-300645
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 17 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients, and their relatives, were invited to do screening for fatty liver by doing conventional abdominal ultrasound (US) by any member of the nutrition clinic team for assessment of liver echopattern.Patients with detected bright liver by US suggestive of fatty liver have undergone an evaluation for the BMI and tests to detect metabolic risk abnormalities.Diagnosis of MAFLD was made when a patient has BMI >25 kg/m2, T2DM or at least two metabolic risk abnormalities.Our study will use either H.pylori stool antigen test (SAT), after stoppage of PPI and antibiotics two weeks before the test, as it cheap and easy, or diagnostic upper endoscopy with biopsy.
Key inclusion criteria (2 listed)
- All patients aged >18 years old.
- Was diagnosed as MAFLD based on abdominal ultrasonography (US) or other imaging techniques.
Key exclusion criteria (6 listed)
- Patients aged ≤18 years old.
- Pregnancy.
- Presence of malignancy.
- Type I DM.
- Patients with fatty liver who undergone bariatric surgeries.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Helicobacter pylori infection in patients with Metabolic Associated Fatty Liver Disease as determined by Urea Breath Test
Time frame: Baseline (Day 1 of hospital admission)
H. pylori infection will be assessed at baseline using a standardized H.pylori antigen in stool. Results will be reported as the proportion (%) of patients with a positive test among all enrolled participants
Prevalence of Helicobacter pylori Infection in Patients with MAFLD
Time frame: At baseline (hospital admission)
Detection of H. pylori infection using [stool antigen test /endoscopic biopsy] in patients diagnosed with MAFLD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira M Assiut University, Lecturer, MD, Trop Med principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection Metabolic Dysfunction-Associated Fatty Liver Disease, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Helicobacter pylori infection in patients with Metabolic Associated Fatty Liver Disease as determined by Urea Breath Test (time frame: Baseline (Day 1 of hospital admission)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.