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Not yet recruitingNCT07805005Updated Sep 9, 2026

NLR and PLR in H. Pylori-Associated Gastritis

An observational study in Helicobacter Pylori Infection, Gastritis and Dyspepsia, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Helicobacter Pylori Infection
  • Gastritis
  • Dyspepsia

Keywords

  • Helicobacter pylori
  • Neutrophil-to-lymphocyte ratio
  • Platelet-to-lymphocyte ratio
  • Gastritis
  • Inflammatory markers
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In context

Gastritis

135 studies on the registry are indexed under Gastritis; 23 are open to participants now.

This study's planned enrollment of 90 is below the median of 200 across 37 observational studies indexed under Gastritis.

Browse Gastritis studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with dyspepsia undergoing endoscopy and biopsy for H. pylori testing at Assiut University Hospitals.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - Age 18 years or older
  • Patients with dyspepsia
  • Patients undergoing endoscopy and for H. pylori testing
  • Willingness to provide

Exclusion criteria

Exclusion Criteria:

  • - Hematological diseases
  • Active infection other than H. pylori
  • Chronic inflammatory or diseases
  • Recent use of or drugs
  • Recent acute bleeding
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
90 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. Platelet-to-lymphocyte ratio (PLR)

    Platelet-to-lymphocyte ratio calculated from complete blood count in patients with and without H. pylori infection.

    Time frame: Baseline

  2. Diagnostic performance of NLR

    Sensitivity, specificity, and optimal cutoff value of NLR for predicting H. pylori infection using receiver operating characteristic (ROC) curve analysis.

    Time frame: Baseline

  3. Diagnostic performance of PLR

    Sensitivity, specificity, and optimal cutoff value of PLR for predicting H. pylori infection using ROC curve analysis.

    Time frame: Baseline

  4. 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.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

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 6145023 ↗
  • Blaser 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 9582144 ↗
  • Zahorec 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 11723675 ↗
  • Farah 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 28374931 ↗
  • Kaplan 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07805005
Lead sponsor
Assiut University
Responsible party
Hadeer Abdelaal Mohamed Mohamed (Resident Physician, Department of Internal Medicine, Assiut University) — Principal investigator
First posted
Sep 4, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
May 1, 2028 (estimated)
Last update
Sep 9, 2026

Study contacts

Hadeer A Mohamed, Resident
Contact
Hadeer.18313571@med.aun.edu.eg
+20 11 25445957
Rania m Hafez, prof
study chair · Internal Medicine Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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