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

Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women in Upper Egypt

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06870773

Enrollment

Registered

2025-03-11

Start date

2025-06-01

Completion date

2026-12-30

Last updated

2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HELICOBACTER PYLORI INFECTIONS, Hyperprolactinaemia

Keywords

H.pylori, prolactin level, hyperprolactinemia

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 48 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Prolactin Levels:	1 month	Prolactin Levels: The primary outcome measure will be the serum prolactin levels in women diagnosed with H. pylori infection compared to those without infection.

Outcome results