NCT07306377

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

2 months

First QC Date

December 12, 2025

Last Update Submit

December 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Atherogenic Index of Plasma (AIP)

    AIP is calculated as log10(triglycerides/HDL cholesterol).

    Baseline (single fasting blood sample at enrollment).

Study Arms (2)

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

Interventions

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Patients older than 18 years.
  • Able to sign the written consent.

You may not qualify if:

  • Unwilling to participate in the study.
  • History of severe metabolic disorders.
  • Taking medications that affect adipose tissue metabolism.
  • History of gastric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Tanta, Egypt

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Tropical Medicine and Infectious Diseases

Study Record Dates

First Submitted

December 12, 2025

First Posted

December 29, 2025

Study Start

January 2, 2025

Primary Completion

February 18, 2025

Study Completion

August 4, 2025

Last Updated

December 29, 2025

Record last verified: 2025-12

Locations