HELICOBACTER PYLORI INFECTIONSNCT06870773
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
An observational study of HELICOBACTER PYLORI INFECTIONS and Hyperprolactinaemia, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS, Hyperprolactinaemia
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 30 Dec 2026
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 48 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women in Upper Egypt
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.
Read the 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.
- Keywords
- H.pylori, prolactin level, hyperprolactinemia
- Medical subject headings
- Hyperprolactinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Maged Ezzat Rasmi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870773
- Sponsor's protocol ID
- Impact of Hpylori on prolactin
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Helicobacter Pylori Infection on Prolactin Levels in Reproductive-Age Women in Upper Egypt
- ClinicalTrials.gov ID
- NCT06870773
- Acronym / sponsor ID
- Impact of Hpylori on prolactin
- Keywords
- H.pylori, prolactin level, hyperprolactinemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prolactin Levels:
Time frame: 1 month
Prolactin Levels: The primary outcome measure will be the serum prolactin levels in women diagnosed with H. pylori infection compared to those without infection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background8. 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.
- Individual participant dataSharing planned: No
Related trials for HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HELICOBACTER PYLORI INFECTIONS and Hyperprolactinaemia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolactin Levels: (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06870773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.