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The research is a cross-sectional observational study conducted at Assiut University Hospital. It will involve 75 women aged 18-45 with confirmed H. pylori infection. The study will measure serum prolactin levels and H. pylori infection status through stool antigen tests. The primary outcome is comparing prolactin levels between H. pylori-positive and negative women. Secondary outcomes include analyzing correlations with clinical symptoms and demographic factors.
Study Design and Setting Cross-sectional observational study
Conducted at Assiut University Hospital
Sample size: 75 women
Participants Inclusion criteria: Women aged 18-45, confirmed H. pylori infection, reproductive age
Exclusion criteria: Recent antibiotic or PPI use, endocrine disorders, chronic illnesses affecting prolactin
Data Collection Participant recruitment from outpatient clinics
Laboratory assessments:
Stool antigen test for H. pylori using ELISA method
Serum prolactin measurement via chemiluminescent immunoassay
Questionnaire for demographic information and medical history
Outcome Measures Primary: Serum prolactin levels in H. pylori-positive vs. negative women
Secondary: Correlation with clinical symptoms and demographic factors
Analysis The study will compare prolactin levels between H. pylori-positive and negative groups, analyze correlations with symptoms, and assess the influence of demographic factors on prolactin levels and H. pylori prevalence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H. pylori-positive reproductive-age women | This group consists of women aged 18-45 years with confirmed H. pylori infection, as determined by stool antigen tests or breath tests and IgM serum. Participants are within reproductive age, not currently pregnant or breastfeeding, and have no known endocrine disorders or chronic illnesses that could affect prolactin levels. The study will measure their serum prolactin levels to investigate the potential association between H. pylori infection and hyperprolactinemia, as well as assess related reproductive health outcomes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Prolactin Levels: | Prolactin Levels: The primary outcome measure will be the serum prolactin levels in women diagnosed with H. pylori infection compared to those without infection. | 1 month |
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Inclusion Criteria:
- 1. Age Range: Women aged 18 to 45 years. 2. Diagnosis of H. pylori Infection: Participants must have a confirmed diagnosis of H. pylori infection through non-invasive methods such as stool antigen tests or breath tests and IgM serum.
3. Reproductive Age: Women must be within reproductive age and not currently pregnant or breastfeeding
Exclusion Criteria:
1. Recent Antibiotic Use: Individuals who have taken antibiotics within the last month will be excluded to avoid interference with H. pylori detection.
2. Use of Proton Pump Inhibitors (PPIs): Patients using PPIs or other medications that affect gastric acid secretion within the last month will be excluded.
3. Endocrine Disorders: Women with known endocrine disorders such as hyperprolactinemia from other causes will be excluded.
4. Chronic Illnesses: Individuals with chronic illnesses that could affect prolactin levels (e.g., renal failure, liver disease) will also be excluded.
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Women aged 18 to 45 years and confirmed diagnosis of H. pylori infection through non-invasive methods such as stool antigen tests or breath tests and IgM serum.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 8. Chittajallu RS, Doraiswamy S, Prakash K, Babu S. Helicobacter pylori infection and its association with hyperprolactinemia: a cross-sectional study. J Clin Diagn Res. 2020;14(3):OC01-OC04. |
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| ID | Term |
|---|---|
| D006966 | Hyperprolactinemia |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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