GastritisNCT06935955
Helicobacter Pylori Gastritis and Its Relation to Metabolic Syndrome Components
An observational study of Gastritis, run by Assiut University.
Trial summary
2.2 Aim 1. To evaluate the association between H. pylori infection and the components of metabolic syndrome. 2. To assess the relationship between the histopathologic features of chronic gastritis evaluated using USS and the components of metabolic syndrome in both H. pylori-positive and H. pylori-negative patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastritis
- What is being tested?
- upper endoscopy
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2025to 1 May 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy.
Who may be able to join
- Patients aged 18 years and above with dyspeptic symptoms
Who cannot join
- People who have a history of H.Pylori eradication or gastric surgery.
- Those who have already received anti-cholesterol therapy.
- Those suffering from severe liver disease, severe kidney disease, or cancer.
About this study
2.2 Aim
- To evaluate the association between H. pylori infection and the components of metabolic syndrome.
- To assess the relationship between the histopathologic features of chronic gastritis evaluated using USS and the components of metabolic syndrome in both H. pylori-positive and H. pylori-negative patients.
Read more
2.4. 2- Study Setting: Department of Pathology, Faculty of Medicine, Assiut University.
- Sample Size Calculation: Sample size was calculated using Epi- Info7. Based on The H. pylori-positive patients were more likely to develop dyslipidemia, and 77.47% of individuals testing positive for H. pylori have higher total cholesterol levels (11). With a confidence limit of 5% and a confidence level of 80%, the minimum number of patients required for this study is 114 cases
2.4.4 -Study tools The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy. Written informed consent will be obtained from all patients participating in the study.
All subjects will be asked to complete a medical history questionnaire, followed by a physical examination (height, body weight, waist circumference, and blood pressure) and laboratory investigations (fasting blood glucose, liver function test, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol( The endoscopy will be carried out by the same specialist, and it will assess chronic and acute gastritis, atrophic gastritis, and metaplasia. The endoscopist will obtain five biopsy samples: two from the antrum, two from the corpus, and one from the incisura.
All biopsies will be processed at the Pathology Department laboratory and embedded in paraffin blocks. For histological examination, two tissue sections will be stained: hematoxylin and eosin (H\&E) and Giemsa stain. Each sample will undergo a double-blind review by two independent pathologists according to the USS (HP, neutrophils, mononuclear cells, atrophy, and intestinal metaplasia), and each variable will be graded semi-quantitatively.
Statistical analysis using suitable tests will be used to assess our results.
2.4.5 -Research outcome measures:
- Primary (main): to evaluate the association between H.pylori gastritis and its relation to metabolic syndrome components
- Secondary (subsidiary):
2.5-Data management and analysis : Data collection All subjects will be asked to complete a medical history questionnaire, followed by a physical examination (height, body weight, waist circumference, and blood pressure) and laboratory investigations (fasting blood glucose, liver function test, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.
Computer software Statistical package for social science (SPSS) program v. 25 (IBM, August 2017).
- Conditions
- Gastritis
- Being tested
- upper endoscopy
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper endoscopyDiagnostic test
All subjects will be asked to complete a medical history questionnaire, followed by physical examination (height, body weight, waist circumference and blood pressure), and laboratory investigations (fasting blood glucose, liver function test, total cholesterol, triglycerides, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol( The endoscopy will be carried out by the same specialist, with assessment of chronic and acute gastritis, atrophic gastritis and metaplasia. The endoscopist will obtain five biopsies samples, two from the antrum, two from the corpus and one from incisura.
All biopsies will be processed at the Pathology Department laboratory and embedded in paraffin blocks. For histological examination, two sets of tissue sections will be stained: one with hematoxylin and eosin (H\&E) and the other with Giemsa stain. Each sample will undergo a double-blind review by two independent pathologists according to the USS (HP, neutrophils, mononuclear cells, atro
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 gastritis patients | The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy Receives: Diagnostic Test: upper endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyslipidemia
we will measure Low-density lipoprotein and serum cholesterol as a marker of dyslipidemia
Measured: periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 May 2025 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Mohmmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935955
- Sponsor's protocol ID
- Helicobacter Pylori Gastritis
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 20 Apr 2025
- 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 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Gastritis and Its Relation to Metabolic Syndrome Components
- ClinicalTrials.gov ID
- NCT06935955
- Acronym / sponsor ID
- Helicobacter Pylori Gastritis
- Conditions
- Gastritis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 Apr 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.
2.2 Aim
- To evaluate the association between H. pylori infection and the components of metabolic syndrome.
- To assess the relationship between the histopathologic features of chronic gastritis evaluated using USS and the components of metabolic syndrome in both H. pylori-positive and H. pylori-negative patients.
2.4. 2- Study Setting: Department of Pathology, Faculty of Medicine, Assiut University.
- Sample Size Calculation: Sample size was calculated using Epi- Info7. Based on The H. pylori-positive patients were more likely to develop dyslipidemia, and 77.47% of individuals testing positive for H. pylori have higher total cholesterol levels (11). With a confidence limit of 5% and a confidence level of 80%, the minimum number of patients required for this study is 114 cases
2.4.4 -Study tools The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy. Written informed consent will be obtained from all patients participating in the study.
All subjects will be asked to complete a medical history questionnaire, followed by a physical examination (height, body weight, waist circumference, and blood pressure) and laboratory investigations (fasting blood glucose, liver function test, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol( The endoscopy will be carried out by the same specialist, and it will assess chronic and acute gastritis, atrophic gastritis, and metaplasia. The endoscopist will obtain five biopsy samples: two from the antrum, two from the corpus, and one from the incisura.
All biopsies will be processed at the Pathology Department laboratory and embedded in paraffin blocks. For histological examination, two tissue sections will be stained: hematoxylin and eosin (H\&E) and Giemsa stain. Each sample will undergo a double-blind review by two independent pathologists according to the USS (HP, neutrophils, mononuclear cells, atrophy, and intestinal metaplasia), and each variable will be graded semi-quantitatively.
Statistical analysis using suitable tests will be used to assess our results.
2.4.5 -Research outcome measures:
- Primary (main): to evaluate the association between H.pylori gastritis and its relation to metabolic syndrome components
- Secondary (subsidiary):
2.5-Data management and analysis : Data collection All subjects will be asked to complete a medical history questionnaire, followed by a physical examination (height, body weight, waist circumference, and blood pressure) and laboratory investigations (fasting blood glucose, liver function test, total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol.
Computer software Statistical package for social science (SPSS) program v. 25 (IBM, August 2017).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort 1 gastritis patients | – | Diagnostic Test: upper endoscopyThe study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include 114 patients diagnosed with gastritis in the Gastroenterology unit and scheduled for upper gastrointestinal endoscopy with stomach biopsy.
Key inclusion criteria (1 listed)
- Patients aged 18 years and above with dyspeptic symptoms
Key exclusion criteria (3 listed)
- People who have a history of H.Pylori eradication or gastric surgery.
- Those who have already received anti-cholesterol therapy.
- Those suffering from severe liver disease, severe kidney disease, or cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upper endoscopyAll subjects will be asked to complete a medical history questionnaire, followed by physical examination (height, body weight, waist circumference and blood pressure), and laboratory investigations (fasting blood glucose, liver function test, total cholesterol, triglycerides, low-density lipoprotein cholesterol and high-density lipoprotein cholesterol( The endoscopy will be carried out by the same specialist, with assessment of chronic and acute gastritis, atrophic gastritis and metaplasia. The endoscopist will obtain five biopsies samples, two from the antrum, two from the corpus and one from incisura. All biopsies will be processed at the Pathology Department laboratory and embedded in paraffin blocks. For histological examination, two sets of tissue sections will be stained: one with hematoxylin and eosin (H\&E) and the other with Giemsa stain. Each sample will undergo a double-blind review by two independent pathologists according to the USS (HP, neutrophils, mononuclear cells, atro | Diagnostic test | cohort 1 gastritis patients |
Primary outcome
Dyslipidemia
Time frame: periprocedural
we will measure Low-density lipoprotein and serum cholesterol as a marker of dyslipidemia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastritis, run by Assiut University.
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 1 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Dyslipidemia (time frame: periprocedural). 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 20 Apr 2025.