Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06870773 | NOT YET RECRUITING | HELICOBACTER PYLORI INFECTIONS

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
Sponsor:

Assiut University

Information provided by (Responsible Party):

Sandra Majid has been officially strengthened

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.

Condition or disease

HELICOBACTER PYLORI INFECTIONS

Hyperprolactinaemia

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 75 participants
Official Title : Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women in Upper Egypt
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-11-30
Estimated Study Completion Date : 2026-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 48 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
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

Location Details

NCT06870773

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found