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NCT Number: 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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • Use of Proton Pump Inhibitors (PPIs): Patients using PPIs or other medications that affect gastric acid secretion within the last month will be excluded.
  • Endocrine Disorders: Women with known endocrine disorders such as hyperprolactinemia from other causes will be excluded.
  • Chronic Illnesses: Individuals with chronic illnesses that could affect prolactin levels (e.g., renal failure, liver disease) will also be excluded.

Treatment and study plan

Primary outcomes

  1. Prolactin Levels:

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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