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

NCT06870773 | Not Yet Recruiting

• 1 other identifier: Impact of Hpylori on prolactin
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HELICOBACTER PYLORI INFECTIONS; Hyperprolactinaemia

Keywords

H.pylori; prolactin level; hyperprolactinemia

Outcome Measures

Primary Outcomes (1)

• Prolactin Levels:

  Prolactin Levels: The primary outcome measure will be the serum prolactin levels in women diagnosed with H. pylori infection compared to those without infection.

  1 month

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• \- 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Hyperprolactinemia

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at the internal medicine department

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 11, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share