Association Between Helicobacter pylori Infection and Anemia Among Adult Patients: A Retrospective Record-Based Study
القسم الأول: معلومات الباحث / Principal Investigator Information
القسم الثاني: تفاصيل الدراسة البحثية / Research Study Details
القسم الثالث: الجوانب الأخلاقية / Ethical Considerations
القسم الرابع: قائمة المرفقات المطلوبة / Required Attachments
القسم الخامس: الإقرار والتوقيع / Acknowledgment and Signature
معلومات الباحث / Researcher Information
Thoraya Salah Murtada Sidahmed
thorayagzzar@gmail.com
0024911308727
Dongola Specialized Hospital
اسم المؤسسة التي سيتم فيها عمل البحث / Name of the institution where the research will be conducted
معلومات الدراسة / Study Information
ورقة علمية / Research Paper
messages.degree_research_paper - messages.degree_research_paper
21,000.00 SDG
1. Background and Rationale Helicobacter pylori (H. pylori) is a Gram-negative bacterium that colonizes the gastric mucosa and infects approximately half of the global population. It is recognized as a major cause of gastritis, peptic ulcer disease, and gastric malignancy. Recently, evidence has also suggested systemic effects of the infection, including nutritional deficiencies and hematological abnormalities such as anemia. Several studies have shown that H. pylori infection is associated with lower hemoglobin levels and higher rates of anemia in adults, independent of iron deficiency status. The mechanisms proposed include chronic gastric inflammation leading to decreased nutrient absorption, reduced gastric acid secretion, occult gastrointestinal blood loss from mucosal erosions, and chronic low-grade inflammation that alters erythropoiesis. For example, a 2023 meta-analysis by Asiimwe et al. found that H. pylori–infected individuals had a significantly higher odds of anemia compared with non-infected individuals (pooled OR = 1.72, 95% CI = 1.31–2.25). Similarly, Haile et al. (2021) in Ethiopia reported anemia prevalence of 31.7% among H. pylori–positive adults compared with 18.2% among negatives. Another large retrospective study by Xu et al. (2017) from China found that H. pylori–infected adults had lower mean hemoglobin concentrations even after adjusting for confounders. Despite these findings, the relationship remains inconsistent across different populations, possibly due to variations in diet, socioeconomic status, and infection patterns. In Sudan and other similar settings, both H. pylori infection and anemia are highly prevalent, yet limited local data exist describing their relationship. Understanding this association may guide clinicians to consider screening and management approaches that address both conditions together. 2. Research Question Is there an association between Helicobacter pylori infection and anemia among adult patients? 3. Objectives General Objective To determine whether Helicobacter pylori infection is associated with anemia among adult patients. Specific Objectives 1. To determine the prevalence of anemia among H. pylori–positive and H. pylori–negative adults. 2. To compare mean hemoglobin levels between H. pylori–positive and H. pylori–negative patients. 3. To identify demographic and clinical predictors of anemia among adults. 4. To assess whether H. pylori infection is an independent predictor of anemia after adjusting for potential confounders. 4. Hypotheses • Null hypothesis (H₀): There is no association between H. pylori infection and anemia among adult patients. • Alternative hypothesis (H₁): H. pylori infection is associated with a higher prevalence of anemia among adult patients. 5. Study Design A retrospective, record-based, cross-sectional study. 6. Study Setting and Period The study will be conducted at Northern state, reviewing medical records of adult patients tested for H. pylori. 7. Study Population Inclusion criteria: • Adults aged 18 years and above. • Documented H. pylori test result (positive or negative) using urea breath test, stool antigen, rapid urease test, or histopathology. • Available complete blood count (CBC) result within 3 months of H. pylori testing. Exclusion criteria: • Known hematologic disorders (e.g., leukemia, thalassemia major). • Recent blood transfusion within 3 months prior to hemoglobin testing. • Pregnancy (due to physiologic anemia). 8. Sample Size Estimation Based on previous studies (e.g., Haile et al., 2021; Asiimwe et al., 2023), anemia prevalence among H. pylori–positive adults ≈ 30% and among negatives ≈ 18%. Using these proportions, with 80% power and α = 0.05, the required sample size per group is ≈ 250 patients, totaling about 500 records (adding 10% for missing data = 550 records). 9. Variables Dependent variable: Anemia status: defined according to WHO criteria Men: Hb < 13 g/dL Non-pregnant women: Hb < 12 g/dL Categorical: anemic = 1; non-anemic = 0 Independent variable: H. pylori infection status (Positive / Negative) Confounding variables: • Age • Sex • Chronic diseases (CKD, liver disease, malignancy) • Use of NSAIDs or anticoagulants • History of GI bleeding • Nutritional status (if available) • Socioeconomic or lifestyle factors (if available) 10. Data Collection Data will be obtained from patient medical records and laboratory databases using a standardized data extraction sheet. Each record will be coded and de-identified before analysis. 11. Data Analysis Descriptive statistics: Mean ± SD for continuous variables, frequencies, and percentages for categorical variables. Bivariate analysis: Chi-square test to compare anemia prevalence by H. pylori status. Independent t-test (or Mann–Whitney U) to compare mean hemoglobin levels. Multivariable analysis: Logistic regression to determine if H. pylori infection is independently associated with anemia, adjusting for confounders. Significance level: p < 0.05 considered statistically significant. Software: Jamovi.
Feb 15, 2026 - Jun 12, 2026
Feb 18, 2026 - Mar 18, 2026
الاعتبارات الأخلاقية / Ethical Considerations
Waiver
All data will be strictly anonymized using unique ID codes instead of names. Since this is a record-based study, a waiver of written consent may be requested, but all personal information will remain completely confidential and accessible only to the research team.
The study will help clinicians determine if H. pylori is a key cause of anemia in the local population, leading to more accurate testing for patients with low blood counts.