Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women to Determine Whether H. Pylori Infection is Associated with Elevated Prolactin Levels and Assess the Clinical Implications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HELICOBACTER PYLORI INFECTIONS, Hyperprolactinaemia. Basic parameters: 18 years — 48 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women in Upper Egypt
Overview
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.
Detailed description
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.
Primary outcome measures
- Prolactin Levels: [Time frame: 1 month]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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.
Identifiers
NCT: NCT06870773 · Impact of Hpylori on prolactin