Clinical trial 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
Official title: Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women in Upper Egypt
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HELICOBACTER PYLORI INFECTIONS
Hyperprolactinaemia
Keywords: H.pylori
prolactin level
hyperprolactinemia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Women aged 18 to 45 years and confirmed diagnosis of H. pylori infection through non-invasive methods such as stool antigen tests or breath tests and IgM serum.

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.

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.

Primary outcomes:
measure: Prolactin Levels:
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.