Helicobacter Pylori InfectionHPE-GINCT07272681
Effect of H. Pylori Eradication on The Improvement of Gastrointestinal Symptoms
An observational study of Helicobacter Pylori Infection and Dyspepsia, run by Amany Usama Ahmed Arafa.
Trial summary
This study aims to evaluate the effect of Helicobacter pylori eradication on gastrointestinal symptoms in adult patients. H. pylori infection is a common cause of dyspepsia and other upper gastrointestinal complaints. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Dyspepsia, Gastrointestinal Symptoms
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 20 Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (≥18 years) diagnosed with Helicobacter pylori infection by invasive or non-invasive tests (urea breath test or stool antigen test) and who have completed standard eradication therapy prescribed by their healthcare providers. The population includes both male and female patients presenting with gastrointestinal symptoms such as dyspepsia.
Who may be able to join
- Adults aged 18 years and older.
- Confirmed diagnosis of Helicobacter pylori infection by one or more diagnostic tests.
- Presence of any upper or lower gastrointestinal symptoms.
- Willingness to undergo H. Pylori eradication therapy and follow-up.
- Ability to provide informed consent.
Who cannot join
- Age less than 18 years.
- The previously unsuccessful application of empirical H. pylori eradication therapy.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs).
- Any malignant disease of the stomach or any other site.
- Any associated comorbidity (renal insufficiency, mental illness).
- History of allergies to proton pump inhibitors or antibiotics.
- Refusal to participate in the survey.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Arafa contact
About this study
Official title: Effect of Helicobacter Pylori Eradication on Gastrointestinal Symptoms in Adult Patients
This study aims to evaluate the effect of Helicobacter pylori eradication on gastrointestinal symptoms in adult patients. H. pylori infection is a common cause of dyspepsia and other upper gastrointestinal complaints. The trial will assess whether successful eradication therapy leads to significant improvement in symptoms compared to baseline. Adult patients diagnosed with H. pylori infection will receive standard eradication treatment, and symptom changes will be monitored using validated questionnaires over a defined follow-up period.
- Medical subject headings
- Dyspepsia
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 adults - Eradication therapy group - Adult patients with H. pylori infection | Adult patients with confirmed Helicobacter pylori infection who have received standard eradication therapy prescribed by their healthcare providers. The study will observe and evaluate changes in gastrointestinal symptoms after completion of the prescribed treatment, without altering or influencing the treatment regimen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal symptoms after Helicobacter pylori eradication.
Gastrointestinal symptom improvement will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS).
The GSRS consists of 15 items, each scored from 1 to 7, giving a total score range of:
Minimum score: 1 (absence of symptoms) Maximum score: 7 (most severe symptoms) Higher scores indicate worse gastrointestinal symptoms. Change will be calculated by comparing baseline scores to follow-up scores after completion of eradication therapy.
Measured: 6 weeks
Eradication success rate.
Proportion of patients achieving confirmed eradication of Helicobacter pylori using non-invasive testing (either urea breath test or stool antigen test), performed after completing eradication therapy.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion20 Jun 2026 (estimated)
- Study completion20 Dec 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 InfectionStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amany Usama Ahmed Arafa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amany Usama Ahmed Arafa, Sohag University
- Investigators
- Amany Usama, Principal investigator, Department of Gastroenterology and Tropical medicine Sohag University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272681
- Sponsor's protocol ID
- Soh-Med--25-11-1MS
- Acronym
- HPE-GI
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Helicobacter Pylori Eradication on Gastrointestinal Symptoms in Adult Patients
- ClinicalTrials.gov ID
- NCT07272681
- Acronym / sponsor ID
- HPE-GI / Soh-Med--25-11-1MS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amany Usama Ahmed ArafaUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 20 Jun 2026 (estimated)
- Study completion
- 20 Dec 2026 (estimated)
- First posted
- 9 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.
This study aims to evaluate the effect of Helicobacter pylori eradication on gastrointestinal symptoms in adult patients. H. pylori infection is a common cause of dyspepsia and other upper gastrointestinal complaints. The trial will assess whether successful eradication therapy leads to significant improvement in symptoms compared to baseline. Adult patients diagnosed with H. pylori infection will receive standard eradication treatment, and symptom changes will be monitored using validated questionnaires over a defined follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H. pylori-positive adults - Eradication therapy group - Adult patients with H. pylori infection | – | –Adult patients with confirmed Helicobacter pylori infection who have received standard eradication therapy prescribed by their healthcare providers. The study will observe and evaluate changes in gastrointestinal symptoms after completion of the prescribed treatment, without altering or influencing the treatment regimen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) diagnosed with Helicobacter pylori infection by invasive or non-invasive tests (urea breath test or stool antigen test) and who have completed standard eradication therapy prescribed by their healthcare providers. The population includes both male and female patients presenting with gastrointestinal symptoms such as dyspepsia.
Key inclusion criteria (5 listed)
- Adults aged 18 years and older.
- Confirmed diagnosis of Helicobacter pylori infection by one or more diagnostic tests.
- Presence of any upper or lower gastrointestinal symptoms.
- Willingness to undergo H. Pylori eradication therapy and follow-up.
- Ability to provide informed consent.
Key exclusion criteria (7 listed)
- Age less than 18 years.
- The previously unsuccessful application of empirical H. pylori eradication therapy.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs).
- Any malignant disease of the stomach or any other site.
- Any associated comorbidity (renal insufficiency, mental illness).
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
Change in gastrointestinal symptoms after Helicobacter pylori eradication.
Time frame: 6 weeks
Gastrointestinal symptom improvement will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The GSRS consists of 15 items, each scored from 1 to 7, giving a total score range of: Minimum score: 1 (absence of symptoms) Maximum score: 7 (most severe symptoms) Higher scores indicate worse gastrointestinal symptoms. Change will be calculated by comparing baseline scores to follow-up scores after completion of eradication therapy.
Eradication success rate.
Time frame: 8 weeks
Proportion of patients achieving confirmed eradication of Helicobacter pylori using non-invasive testing (either urea breath test or stool antigen test), performed after completing eradication therapy.
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 16 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Arafa contact
Amany Usama principal investigator
Department of Gastroenterology and Tropical medicine Sohag University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection and Dyspepsia, run by Amany Usama Ahmed Arafa.
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 5 inclusion and 7 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 16 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 Amany Usama (+201113063055, Amany_osama_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gastrointestinal symptoms after Helicobacter pylori eradication. (time frame: 6 weeks). 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 16 Dec 2025.