H Pylori InfectionHP-AIPNCT07306377
H. Pylori Infection and AIP Levels
An observational study of H Pylori Infection and Atherogenic Plasma Index, run by Tanta University at 1 site in Egypt.
Trial summary
Helicobacter pylori is a common bacterial infection of the stomach that can cause ulcers and other digestive problems. Recent studies suggest that this infection may also affect metabolism and blood fats (lipids), which are important for heart health. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- H Pylori Infection, Atherogenic Plasma Index
- What is being tested?
- urea breath test
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2025to 4 Aug 2025
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (≥18 years) attending the Gastroenterology Unit at Tanta University Hospitals (Egypt) and the Internal Medicine Department at Tadawi Hospital (Saudi Arabia). Participants will include both men and women diagnosed with or without H. pylori infection, recruited consecutively during routine clinical visits.
Who may be able to join
- Patients older than 18 years.
- Able to sign the written consent.
- Willing to participate in the research and undergo H. pylori testing. Exclusion criteria
- Unwilling to participate in the study.
- History of severe metabolic disorders.
- Taking medications that affect adipose tissue metabolism.
- History of gastric surgery.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Helicobacter Pylori Infection as A Potential Risk Factor for Dyslipidemia: Insights From Atherogenic Index of Plasma (AIP)
Helicobacter pylori is a common bacterial infection of the stomach that can cause ulcers and other digestive problems. Recent studies suggest that this infection may also affect metabolism and blood fats (lipids), which are important for heart health. Changes in lipid levels, such as higher triglycerides and lower "good" cholesterol (HDL), can increase the risk of cardiovascular disease.
This study will examine whether H. pylori infection is linked to changes in lipid profiles, especially the Atherogenic Index of Plasma (AIP). AIP is a calculation based on triglycerides and HDL cholesterol that helps predict the risk of heart disease.
- Conditions
- H Pylori Infection, Atherogenic Plasma Index
- Being tested
- urea breath test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urea breath testDiagnostic test
Participants will undergo a urea breath test to confirm H. pylori infection status.
Fasting blood samples will be collected to measure triglycerides and HDL cholesterol, and the Atherogenic Index of Plasma (AIP) will be calculated.
| Study group | Role | What they receive |
|---|---|---|
| Group 1A: H. pylori Positive - Normal AIP Group 1B: H. pylori Positive - Elevated AIP Group 2: H. | Not described Receives: Diagnostic Test: urea breath test | |
| Group 1A: H. pylori Positive - Normal AIP, 1B: H. pylori Positive - Elevated AIP, Group 2: H. | Not described Receives: Diagnostic Test: urea breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Atherogenic Index of Plasma (AIP)
AIP is calculated as log10(triglycerides/HDL cholesterol).
Measured: Baseline (single fasting blood sample at enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start2 Jan 2025
- Primary completion18 Feb 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Ahmed Khalaf, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306377
- Sponsor's protocol ID
- Helicobacter Pylori and AIP
- Acronym
- HP-AIP
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helicobacter Pylori Infection as A Potential Risk Factor for Dyslipidemia: Insights From Atherogenic Index of Plasma (AIP)
- ClinicalTrials.gov ID
- NCT07306377
- Acronym / sponsor ID
- HP-AIP / Helicobacter Pylori and AIP
- Conditions
- H Pylori Infection, Atherogenic Plasma Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 29 Dec 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.
Helicobacter pylori is a common bacterial infection of the stomach that can cause ulcers and other digestive problems. Recent studies suggest that this infection may also affect metabolism and blood fats (lipids), which are important for heart health. Changes in lipid levels, such as higher triglycerides and lower "good" cholesterol (HDL), can increase the risk of cardiovascular disease.
This study will examine whether H. pylori infection is linked to changes in lipid profiles, especially the Atherogenic Index of Plasma (AIP). AIP is a calculation based on triglycerides and HDL cholesterol that helps predict the risk of heart disease.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1A: H. pylori Positive - Normal AIP Group 1B: H. pylori Positive - Elevated AIP Group 2: H. | – | Diagnostic Test: urea breath test |
| Group 1A: H. pylori Positive - Normal AIP, 1B: H. pylori Positive - Elevated AIP, Group 2: H. | – | Diagnostic Test: urea breath test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) attending the Gastroenterology Unit at Tanta University Hospitals (Egypt) and the Internal Medicine Department at Tadawi Hospital (Saudi Arabia). Participants will include both men and women diagnosed with or without H. pylori infection, recruited consecutively during routine clinical visits.
Key inclusion criteria (7 listed)
- Patients older than 18 years.
- Able to sign the written consent.
- Willing to participate in the research and undergo H. pylori testing. Exclusion criteria
- Unwilling to participate in the study.
- History of severe metabolic disorders.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| urea breath testParticipants will undergo a urea breath test to confirm H. pylori infection status. Fasting blood samples will be collected to measure triglycerides and HDL cholesterol, and the Atherogenic Index of Plasma (AIP) will be calculated. | Diagnostic test | Group 1A: H. pylori Positive - Normal AIP Group 1B: H. pylori Positive - Elevated AIP Group 2: H., Group 1A: H. pylori Positive - Normal AIP, 1B: H. pylori Positive - Elevated AIP, Group 2: H. |
Primary outcome
Atherogenic Index of Plasma (AIP)
Time frame: Baseline (single fasting blood sample at enrollment).
AIP is calculated as log10(triglycerides/HDL cholesterol).
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 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for H Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 H Pylori Infection and Atherogenic Plasma Index, run by Tanta 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 7 inclusion and 0 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 29 Dec 2025. 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?
Atherogenic Index of Plasma (AIP) (time frame: Baseline (single fasting blood sample at enrollment).). 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 29 Dec 2025.