NCT06870773

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
• Phase: —
• Study type: Observational
• Enrollment: 75 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HELICOBACTER PYLORI INFECTIONS
• Hyperprolactinaemia

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-11-30
• Completion: 2026-12-30
• First posted: 2025-03-11
• Last updated: 2025-03-11