Helicobacter Pylori Infection, Susceptibility toNCT07293169
Helicobacter Pylori Infection Among Women With Recurrent Abortion of Unknown Cause
An observational study of Helicobacter Pylori Infection, Susceptibility to, run by Assiut University.
Trial summary
Helicobacter pylori (H. pylori) infection affects approximately one half of the world population and it is more prevalent in developing countries. This microorganism colonizes the stomach. Typically, it is acquired during childhood and causes asymptomatic chronic infection. A small portion of H. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Susceptibility to
- What is being tested?
- H pylori eradication
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2026
- How long will I take part?
- 1 Year
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: • All woman with repeated abortion of Unknwon cause.
Who may be able to join
None listed.
Who cannot join
- Known uterine anatomical causes of abortion.
- Current systemic antibiotic use and PPIs within 2 weeks.
- Medical diseases as (Thyroid disorders , DM,HTN).
- Antiphspholipid syndrome.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Mostafa Gamal Ahmed Mostafa موشا -مركز اسيوط -محافظة اسيوط contact
About this study
Official title: H.Pylori Infection Among Women With Recurrent Abortion of Unknown Cause
- Helicobacter pylori (H. pylori) infection affects approximately one half of the world population and it is more prevalent in developing countries. This microorganism colonizes the stomach. Typically, it is acquired during childhood and causes asymptomatic chronic infection. A small portion of H. pylori infected subjects develop peptic ulcers and gastric carcinoma, usually during late adulthood. (1,2)
- Some studies show a relationship between H.pylori and pregnancy-related disorders, such as fetal growth defects and malformations, miscarriage and, more recently, to pre-eclampsia. (3)
- Abortion is one of the most common complications of pregnancy. Infection is one of the main causes of abortion, a cause which is more important in spontaneous abortion; infections account for only 5% of recurrent abortions. (4)
- The severity of infection with H.pylori: given the increasing secretion of inflammatory cytokines and CD8 +, CD4 + in T cells and increasing interferons (IFN), studies have shown that infection with Helicobacter pylori activates immune cells in the uterus and endometrial surface cells, increases TH1 response to helicobacter, disturbs the ratio of T-Helper 2 / T-Helper 1 cytokines, causes abnormalities in the formation of natural vessels in the uterus and, ultimately, leads to abortion.(5)
- Repeated spontaneous abortion (RSA): >=2 consecutive spontaneous pregnancy losses before 20 weeks gestation.(6)
- To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause........
Read the detailed description
3.Patients and methods
Study design:
Case Control study two groups (one group of 50 women with history of recurrent abortion and another group of 50 women without recurrent of abortion)
Study location:
the study will be conducted in Assiut university hospitals (women's health hospital) .
Study duration:
the study will be carried out from October 2025 till October 2026.
Sample size :
the calculated sample size for two groups 100 cases (one group of 50 women with history of recurrent abortion and another group of 50 women without recurrent of abortion).
4.Inclusion criteria
- All woman with repeated abortion of Unknwon cause.
- Not received H.pylori eradication therapy in prior 3 months . 5.Exclusion criteria
- Known uterine anatomical causes of abortion.
- Current systemic antibiotic use and PPIs within 2 weeks.
- Medical diseases as (Thyroid disorders , DM,HTN).
- Antiphspholipid syndrome. 6.Methods
- Case Control study at Assiut woman's heath hospital from October 2025 till October 2026.
- Case Control study two groups (one group of women with history of recurrent abortion and another group of women without recurrent of abortion) by stool antigen test. 7.All patients will be subjected to the following
- Complete obstetric history , medical history, smoking ,alcohol, recent antibiotics ,PPIs , socioeconomic status
- Laboratory samples :
H.pylori antigen in stool ,complete blood count , abdominopelvic ultrasound , urine analysis , liver and kidney function tests ,TSH , prolactin and any necessary investigation will be done.
Anti cardiolipin (IgM , IgG) ,Lupus anti coagulant and Anti B2 glycoproteinA1 (IgM, IgG) and 3D US on uterus . 8.Ethical considerations
- All subjects will provide written informed consent to participate in the study .
- The protocol of the study will be presented to the local ethics committee for approval. 9.Statistical analysis
- Statistical analysis will be performed using Spss version 23. 10.References
- 1. Malaty HM. Epidemiology of Helicobacter pylori infection. Best Pract Res Clin Gastroenterol 2007; 21: 205-214
- 2. Suerbaum S, Michetti P. Helicobacter pylori infection. N Engl J Med 2002; 347: 1175-1186
- 3. Chen MJ, Fang YJ, Wu MS, Chen CC, Chen YN, Yu CC et al. Application of Helicobacter pylori stool antigen test to survey the updated prevalence of Helicobacter pylori infection in Taiwan. 2020;35:233-40
- 4. Ambühl LM, Baandrup U, Dybkær K,Blaakær J, Uldbjerg N, Sørensen S. Human papillomavirus infection as a possible cause of spontaneous abortion and spontaneous preterm delivery 2016;2016.
- 5. Azami M, Nasirkandy MP, Mansouri A, Darvishi Z, Rahmati S, Abangah G, DehghanHR, Borji M, Abbasalizadeh S. GGollobal Prevelance of H.pylori infection in pregnant women: a systematic review and meta-analysis study. Int J Women's Health Reprod Sci. 2017;5:30-6.
- 6. Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013 99:63.
- Being tested
- H pylori eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H pylori eradicationDiagnostic test
h.pylori stool antigen
| Study group | Role | What they receive |
|---|---|---|
| one group of women with history of recurrent abortion | another group of women without recurrent of abortion Receives: Diagnostic Test: H pylori eradication |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause
Measured: baseline
H.pylori infection among women with recurrent abortion of unknown cause
- To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause........
Measured: the study will be carried out from October 2025 till October 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Infection, Susceptibility toStudies 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
- Case-control
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Gamal Ahmed Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293169
- Sponsor's protocol ID
- H.pylori infection e abortion
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- H.Pylori Infection Among Women With Recurrent Abortion of Unknown Cause
- ClinicalTrials.gov ID
- NCT07293169
- Acronym / sponsor ID
- H.pylori infection e abortion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 19 Dec 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.
- Helicobacter pylori (H. pylori) infection affects approximately one half of the world population and it is more prevalent in developing countries. This microorganism colonizes the stomach. Typically, it is acquired during childhood and causes asymptomatic chronic infection. A small portion of H. pylori infected subjects develop peptic ulcers and gastric carcinoma, usually during late adulthood. (1,2)
- Some studies show a relationship between H.pylori and pregnancy-related disorders, such as fetal growth defects and malformations, miscarriage and, more recently, to pre-eclampsia. (3)
- Abortion is one of the most common complications of pregnancy. Infection is one of the main causes of abortion, a cause which is more important in spontaneous abortion; infections account for only 5% of recurrent abortions. (4)
- The severity of infection with H.pylori: given the increasing secretion of inflammatory cytokines and CD8 +, CD4 + in T cells and increasing interferons (IFN), studies have shown that infection with Helicobacter pylori activates immune cells in the uterus and endometrial surface cells, increases TH1 response to helicobacter, disturbs the ratio of T-Helper 2 / T-Helper 1 cytokines, causes abnormalities in the formation of natural vessels in the uterus and, ultimately, leads to abortion.(5)
- Repeated spontaneous abortion (RSA): >=2 consecutive spontaneous pregnancy losses before 20 weeks gestation.(6)
- To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause........
Detailed description
3.Patients and methods
Study design:
Case Control study two groups (one group of 50 women with history of recurrent abortion and another group of 50 women without recurrent of abortion)
Study location:
the study will be conducted in Assiut university hospitals (women's health hospital) .
Study duration:
the study will be carried out from October 2025 till October 2026.
Sample size :
the calculated sample size for two groups 100 cases (one group of 50 women with history of recurrent abortion and another group of 50 women without recurrent of abortion).
4.Inclusion criteria
- All woman with repeated abortion of Unknwon cause.
- Not received H.pylori eradication therapy in prior 3 months . 5.Exclusion criteria
- Known uterine anatomical causes of abortion.
- Current systemic antibiotic use and PPIs within 2 weeks.
- Medical diseases as (Thyroid disorders , DM,HTN).
- Antiphspholipid syndrome. 6.Methods
- Case Control study at Assiut woman's heath hospital from October 2025 till October 2026.
- Case Control study two groups (one group of women with history of recurrent abortion and another group of women without recurrent of abortion) by stool antigen test. 7.All patients will be subjected to the following
- Complete obstetric history , medical history, smoking ,alcohol, recent antibiotics ,PPIs , socioeconomic status
- Laboratory samples :
H.pylori antigen in stool ,complete blood count , abdominopelvic ultrasound , urine analysis , liver and kidney function tests ,TSH , prolactin and any necessary investigation will be done.
Anti cardiolipin (IgM , IgG) ,Lupus anti coagulant and Anti B2 glycoproteinA1 (IgM, IgG) and 3D US on uterus . 8.Ethical considerations
- All subjects will provide written informed consent to participate in the study .
- The protocol of the study will be presented to the local ethics committee for approval. 9.Statistical analysis
- Statistical analysis will be performed using Spss version 23. 10.References
- 1. Malaty HM. Epidemiology of Helicobacter pylori infection. Best Pract Res Clin Gastroenterol 2007; 21: 205-214
- 2. Suerbaum S, Michetti P. Helicobacter pylori infection. N Engl J Med 2002; 347: 1175-1186
- 3. Chen MJ, Fang YJ, Wu MS, Chen CC, Chen YN, Yu CC et al. Application of Helicobacter pylori stool antigen test to survey the updated prevalence of Helicobacter pylori infection in Taiwan. 2020;35:233-40
- 4. Ambühl LM, Baandrup U, Dybkær K,Blaakær J, Uldbjerg N, Sørensen S. Human papillomavirus infection as a possible cause of spontaneous abortion and spontaneous preterm delivery 2016;2016.
- 5. Azami M, Nasirkandy MP, Mansouri A, Darvishi Z, Rahmati S, Abangah G, DehghanHR, Borji M, Abbasalizadeh S. GGollobal Prevelance of H.pylori infection in pregnant women: a systematic review and meta-analysis study. Int J Women's Health Reprod Sci. 2017;5:30-6.
- 6. Practice Committee of the American Society for Reproductive Medicine. Definitions of infertility and recurrent pregnancy loss: a committee opinion. Fertil Steril. 2013 99:63.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one group of women with history of recurrent abortion | – | Diagnostic Test: H pylori eradicationanother group of women without recurrent of abortion |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- • All woman with repeated abortion of Unknwon cause.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Known uterine anatomical causes of abortion.
- Current systemic antibiotic use and PPIs within 2 weeks.
- Medical diseases as (Thyroid disorders , DM,HTN).
- Antiphspholipid syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H pylori eradicationh.pylori stool antigen | Diagnostic test | one group of women with history of recurrent abortion |
Primary outcome
• To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause
Time frame: baseline
H.pylori infection among women with recurrent abortion of unknown cause
Time frame: the study will be carried out from October 2025 till October 2026
• To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause........
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 19 Dec 2025.
Related trials for Helicobacter Pylori Infection, Susceptibility to
RecruitingObservational study
Prevalence and Trends of Antimicrobial Resistance of Helicobacter Pylori in Korea
Helicobacter Pylori Infection, Helicobacter Pylori Associated Gastrointestinal Disease
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.
Mostafa Gamal Ahmed Mostafa موشا -مركز اسيوط -محافظة اسيوط contact
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, Susceptibility to, 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 0 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 19 Dec 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?
Contact Mostafa Gamal Ahmed Mostafa موشا -مركز اسيوط -محافظة اسيوط (01095773806 ext. 01095773806, Moustafa.15235564@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• To determine if H.pylori infection is significantly associated with recurrent abortion of unknown cause (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2025.