An observational study in HELICOBACTER PYLORI INFECTIONS and Hyperprolactinaemia, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years to 48 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Assiut University · Observational
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.
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.
39 studies on the registry are indexed under Hyperprolactinemia; 4 are open to participants now.
This study's planned enrollment of 75 is below the median of 114 across 16 observational studies indexed under Hyperprolactinemia.
Browse Hyperprolactinemia studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Recent Antibiotic Use: Individuals who have taken antibiotics within the last month will be excluded to avoid interference with H. pylori detection.
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.
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.
Time frame: 1 month
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jun 2025; primary completion for Nov 2026, 17 months later.
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This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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