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Association Between Helicobacter pylori Infection and Anemia Among Adult Patients: A Retrospective Record-Based Study

ETH-20260207-0122 تاريخ التقديم: Feb 07, 2026 / Submitted: Feb 07, 2026
قيمة الرسوم / Payment Amount
21,000.00 SDG
نوع البحث / Research Type
ورقة علمية / Research Paper
فترة الدراسة / Study Period
Feb 15, 2026 - Jun 12, 2026
Approved
السودان - الولاية الشمالية
وزارة الصحة
الادارة العامة للتخطيط والتنمية الصحية
إدارة البحوث
لجنة الموافقة الأخلاقية
طلب الموافقة الأخلاقية - Ethical Approval Request Form
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Ethical Approval Request Form
General Administration for Planning and Health Development
Research Department
Ethical Approval Committee
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رقم التسلسل
Serial Number
SER-20260207-0122
رقم الطلب
Request Number
ETH-20260207-0122
تاريخ تقديم الطلب
Date of Submission
2026-02-07

القسم الأول: معلومات الباحث / Principal Investigator Information

1. الاسم الكامل للباحث الرئيسي
Principal Investigator Full Name
Thoraya Salah Murtada Sidahmed
2. الجهة التي ينتمي إليها
Affiliation Type
جامعة / University: Alzaiem Alazhary University - Faculty of Medicine
Alzaiem Alazhary University - Faculty of Medicine
3. الوظيفة / اللقب العلمي
Job Title/Academic Degree
-
4. البريد الإلكتروني
Email Address
thorayagzzar@gmail.com
5. رقم الهاتف
Phone Number
0024911308727
المشرف / Supervisor
الاسم الكامل / Full Name
Dalal Nooreldein Mohamadin
البريد الإلكتروني / Email
-
الوظيفة / اللقب العلمي / Job Title
-
رقم الهاتف / Phone
-
القسم / المؤسسة / Department
-

القسم الثاني: تفاصيل الدراسة البحثية / Research Study Details

7. عنوان الدراسة
Study Title
Association Between Helicobacter pylori Infection and Anemia Among Adult Patients: A Retrospective Record-Based Study
8. نوع البحث (يرجى التحديد)
Type of Research (Please select)
☐دكتوراه / PhD
☐ماجستير / Master's
☐بكالوريوس / Bachelor's
☐دبلوم عالي / Postgraduate Diploma
☐دبلوم وسيط / Intermediate Diploma
☑ورقة علمية / Research Paper
☐تقرير علمي / Scientific Report
☐أبحاث طبية / Medical Research
☐أخرى / Other
9. وصف مختصر للبحث
Brief Description of Research
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.

القسم الثالث: الجوانب الأخلاقية / Ethical Considerations

10. طريقة الحصول على الموافقة من المشاركين
Method of Obtaining Consent from Participants
☐مكتوبة / Written
☐شفهية / Verbal
☐غير مطبقة / Not Applicable
☐ضمنية / Implied
☑إعفاء / Waiver
يرجى إرفاق نموذج الموافقة / Please attach consent form
11. آلية الحفاظ على سرية المعلومات
Confidentiality Measures
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.
12. مدى المخاطر على المشاركين
Risk Level to Participants
☐لا توجد / None
☑طفيفة / Minor
☐متوسطة / Moderate
☐عالية / High
يرجى توضيح أي مخاطر محتملة وخطة التعامل معها / Please describe any potential risks and mitigation:
-
13. الفوائد المحتملة للمشاركين أو المجتمع
Potential Benefits to Participants or Society
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.
14. هل تشمل الدراسة فئات ضعيفة؟
Does the study involve vulnerable groups?
☐الأطفال / Children
☐النساء الحوامل / Pregnant Women
☐اللاجئون/النازحون / Refugees/Displaced
☐ذوو الإعاقة / People with Disabilities
☐أخرى / Other:

القسم الرابع: قائمة المرفقات المطلوبة / Required Attachments

نسخة من المقترح البحثي الكامل
Full Research Proposal
أدوات جمع البيانات
Data Collection Tools
خطاب تسهيل من الجامعة
University Facilitation Letter

القسم الخامس: الإقرار والتوقيع / Acknowledgment and Signature

أُقر أنا الموقع أدناه بأن جميع المعلومات الواردة في هذه الاستمارة صحيحة وكاملة، وأتعهد بعدم البدء في أي جزء من الدراسة قبل الحصول على الموافقة الأخلاقية الرسمية، والالتزام بجميع الإرشادات والمعايير الأخلاقية المعتمدة من قبل لجنة الموافقة الأخلاقية.
I, the undersigned, acknowledge that all information provided in this form is accurate and complete, and I agree not to begin any part of the study before receiving official ethical approval, and to comply with all ethical guidelines and standards approved by the Ethical Approval Committee.
اسم الباحث الرئيسي / Principal Investigator Name
Thoraya Salah Murtada Sidahmed
التوقيع / Signature
_______________________
التاريخ / Date
2026-02-07

معلومات الباحث / Researcher Information

T

Thoraya Salah Murtada Sidahmed

thorayagzzar@gmail.com

0024911308727

جامعة: Alzaiem Alazhary University الكلية: Faculty of Medicine

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

مخاطر منخفضة - Low Risk

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.