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

NCT ID: NCT06870773

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-30

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.

Conditions

HELICOBACTER PYLORI INFECTIONS; Hyperprolactinaemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Sandra Maged Ezzat Rasmi

resident at the internal medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

Other Identifiers

Impact of Hpylori on prolactin

Identifier Type: -

Identifier Source: org_study_id