Helicobacter Pylori InfectionNCT07805005
NLR and PLR in H. Pylori-Associated Gastritis
An observational study of Helicobacter Pylori Infection and Gastritis, run by Assiut University.
Trial summary
This cross-sectional study aims to evaluate the role of neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) as inflammatory markers in patients with Helicobacter pylori-associated gastritis at Assiut University Hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Helicobacter Pylori Infection, Gastritis, Dyspepsia
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 1 May 2028
- 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: Adult patients with dyspepsia undergoing endoscopy and biopsy for H. pylori testing at Assiut University Hospitals.
Who may be able to join
- - Age 18 years or older
- Patients with dyspepsia
- Patients undergoing endoscopy and biopsy for H. pylori testing
- Willingness to provide informed consent
Who cannot join
- - Hematological diseases
- Active infection other than H. pylori
- Chronic inflammatory or autoimmune diseases
- Malignancy
- Recent use of steroids or immunosuppressive drugs
- Recent acute bleeding
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Platelet-to-Lymphocyte Ratio and Neutrophil-to-Lymphocyte Ratio in Patients With Helicobacter Pylori-Associated Gastritis
This cross-sectional study aims to evaluate the role of neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) as inflammatory markers in patients with Helicobacter pylori-associated gastritis at Assiut University Hospitals.
Read the detailed description
Helicobacter pylori is a major cause of gastritis and is associated with chronic gastric inflammation. Systemic inflammatory markers derived from complete blood count, such as the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), have been proposed as simple and inexpensive indicators of inflammation.
This cross-sectional study will include adult patients with dyspepsia undergoing testing for H. pylori by endoscopy and biopsy at Assiut University Hospitals. Complete blood count will be performed to calculate NLR and PLR. The study will assess the association of these ratios with the presence of H. pylori infection and the severity of gastritis.
- Conditions
- Helicobacter Pylori Infection, Gastritis, Dyspepsia
- Keywords
- Helicobacter pylori, Neutrophil-to-lymphocyte ratio, Platelet-to-lymphocyte ratio, Gastritis, Inflammatory markers
- Medical subject headings
- Gastritis, Dyspepsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil-to-lymphocyte ratio (NLR) in H. pylori-associated gastritis
Neutrophil-to-lymphocyte ratio calculated from complete blood count in patients with confirmed H. pylori-associated gastritis compared with patients without H. pylori infection.
Measured: Baseline
Secondary outcomes (4)
Platelet-to-lymphocyte ratio (PLR)
Platelet-to-lymphocyte ratio calculated from complete blood count in patients with and without H. pylori infection.
Measured: Baseline
Diagnostic performance of NLR
Sensitivity, specificity, and optimal cutoff value of NLR for predicting H. pylori infection using receiver operating characteristic (ROC) curve analysis.
Measured: Baseline
Diagnostic performance of PLR
Sensitivity, specificity, and optimal cutoff value of PLR for predicting H. pylori infection using ROC curve analysis.
Measured: Baseline
Correlation of NLR and PLR with severity of gastritis
Correlation coefficient between neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) values and the severity grade of gastritis based on endoscopic and/or histopathological findings, using Spearman or Pearson correlation as appropriate.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Abdelaal Mohamed Mohamed, Assiut University
- Investigators
- Rania m Hafez, prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805005
- Sponsor's protocol ID
- HP-NLR-PLR-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marshall BJ, Warren JR. Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration. Lancet. 1984 Jun 16;1(8390):1311-5. doi: 10.1016/s0140-6736(84)91816-6.
PubMed 6145023Blaser MJ. Helicobacter pylori and gastric diseases. BMJ. 1998 May 16;316(7143):1507-10. doi: 10.1136/bmj.316.7143.1507. No abstract available.
PubMed 9582144Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak.
PubMed 11723675Farah R, Hamza H, Khamisy-Farah R. A link between platelet to lymphocyte ratio and Helicobacter pylori infection. J Clin Lab Anal. 2018 Jan;32(1):e22222. doi: 10.1002/jcla.22222. Epub 2017 Apr 4.
PubMed 28374931Kaplan M, Ates I, Yuksel M, Arikan MF, Aydog G, Turhan N, Gokbulut V, Kayacetin E. The role of the PLR-NLR combination in the prediction of the presence of Helicobacter pylori and its associated complications. Saudi J Gastroenterol. 2018 Sep-Oct;24(5):294-300. doi: 10.4103/sjg.SJG_29_18.
PubMed 29873316
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet-to-Lymphocyte Ratio and Neutrophil-to-Lymphocyte Ratio in Patients With Helicobacter Pylori-Associated Gastritis
- ClinicalTrials.gov ID
- NCT07805005
- Acronym / sponsor ID
- HP-NLR-PLR-Assiut-2026
- Conditions
- Helicobacter Pylori Infection, Gastritis, Dyspepsia
- Keywords
- Helicobacter pylori, Neutrophil-to-lymphocyte ratio, Platelet-to-lymphocyte ratio, Gastritis, Inflammatory markers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 4 Sep 2026 (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.
This cross-sectional study aims to evaluate the role of neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR) as inflammatory markers in patients with Helicobacter pylori-associated gastritis at Assiut University Hospitals.
Detailed description
Helicobacter pylori is a major cause of gastritis and is associated with chronic gastric inflammation. Systemic inflammatory markers derived from complete blood count, such as the neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), have been proposed as simple and inexpensive indicators of inflammation.
This cross-sectional study will include adult patients with dyspepsia undergoing testing for H. pylori by endoscopy and biopsy at Assiut University Hospitals. Complete blood count will be performed to calculate NLR and PLR. The study will assess the association of these ratios with the presence of H. pylori infection and the severity of gastritis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with dyspepsia undergoing endoscopy and biopsy for H. pylori testing at Assiut University Hospitals.
Key inclusion criteria (4 listed)
- - Age 18 years or older
- Patients with dyspepsia
- Patients undergoing endoscopy and biopsy for H. pylori testing
- Willingness to provide informed consent
Key exclusion criteria (6 listed)
- - Hematological diseases
- Active infection other than H. pylori
- Chronic inflammatory or autoimmune diseases
- Malignancy
- Recent use of steroids or immunosuppressive drugs
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
Neutrophil-to-lymphocyte ratio (NLR) in H. pylori-associated gastritis
Time frame: Baseline
Neutrophil-to-lymphocyte ratio calculated from complete blood count in patients with confirmed H. pylori-associated gastritis compared with patients without H. pylori infection.
4 secondary outcomes
Platelet-to-lymphocyte ratio (PLR)
Time frame: Baseline
Diagnostic performance of NLR
Time frame: Baseline
Diagnostic performance of PLR
Time frame: Baseline
Correlation of NLR and PLR with severity of gastritis
Time frame: Baseline
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 9 Sep 2026.
- Background: PubMed 6145023Marshall BJ, Warren JR. Unidentified curved bacilli in the stomach of patients with gastritis and peptic ulceration. Lancet. 1984 Jun 16;1(8390):1311-5. doi: 10.1016/s0140-6736(84)91816-6.
- Background: PubMed 9582144Blaser MJ. Helicobacter pylori and gastric diseases. BMJ. 1998 May 16;316(7143):1507-10. doi: 10.1136/bmj.316.7143.1507. No abstract available.
- Background: PubMed 11723675Zahorec R. Ratio of neutrophil to lymphocyte counts--rapid and simple parameter of systemic inflammation and stress in critically ill. Bratisl Lek Listy. 2001;102(1):5-14. English, Slovak.
- Background: PubMed 28374931Farah R, Hamza H, Khamisy-Farah R. A link between platelet to lymphocyte ratio and Helicobacter pylori infection. J Clin Lab Anal. 2018 Jan;32(1):e22222. doi: 10.1002/jcla.22222. Epub 2017 Apr 4.
- Background: PubMed 29873316Kaplan M, Ates I, Yuksel M, Arikan MF, Aydog G, Turhan N, Gokbulut V, Kayacetin E. The role of the PLR-NLR combination in the prediction of the presence of Helicobacter pylori and its associated complications. Saudi J Gastroenterol. 2018 Sep-Oct;24(5):294-300. doi: 10.4103/sjg.SJG_29_18.
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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.
Rania m Hafez, prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and 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 4 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: opening soon, as of the sponsor's last update on 9 Sep 2026. 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?
Contact Hadeer A Mohamed, Resident (+20 11 25445957, Hadeer.18313571@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil-to-lymphocyte ratio (NLR) in H. pylori-associated gastritis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07805005, which also lists 5 linked publications.
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 9 Sep 2026.