GERDNCT06457334
Effect of Helicobacter Pylori Eradication on Gastroesophageal RefIux Disease (GERD)
An observational study of GERD, run by Assiut University at 1 site in Egypt.
Trial summary
Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and symptoms improvement Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- GERD
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients diagnosed as GERD clinically and endscopically.
Who may be able to join
- All patients diagnosed as GERD clinically and endscopically.
Who cannot join
- NO exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and symptoms improvement
Read the detailed description
HeIicobacter PyIori (H.pyIori) is a gram-negative spiral shaped bacterium that affects up to 50% of the population worldwide, with a higher prevalences in the developing countries,Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus, resulting in a significant economic burden in direct and indirect costs and adversely affects the quality of life.GERD is caused by multiple different mechanisms that can be intrinsic, structural, or both, leading to the disruption of the esophago-gastric junction barrier resulting in exposure of the esophagus to acidic gastric contents, Clinically, GERD typically manifests with symptoms of heartburn and regurgitation. It can also present in an atypical fashion with extra-esophageal symptoms such as chest pain, dental erosions, chronic cough, laryngitis, or asthma.The relationship between H. pylori and gastroesophageal reflux disease (GERD) is still unclear, and the effect of H. pylori eradication on GERD treatment is unknown.Several studies have shown the inverse relationship between the occurrence of GERD and H.pyIori infection, in particular an increased severity of the disease is documented in patients with pre-existing symptoms .It has been showed that a markedly resolution of dyspepsia in patients at whom the eradication therapy was successful when compared with subjects with a persistent infection
- Conditions
- GERD
- Keywords
- Helicobacter pylori
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication of Helicobacter pylori after triple therapy
H.pylori eradication will be assessed using the endoscope
Measured: 1\2024 to 12\2024
Effect of Helicobacter pylori eradication on Gastroesophageal RefIux disease (GERD) syptomes
Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and correlate with GERD symptoms improvement.
Measured: 1\2024 to 12\2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jan 2025 (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 GERDStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Fergany Abdelhamid Elgamal, Assiut University
- Investigators
- Saad Z Mahmoud, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457334
- Sponsor's protocol ID
- H.pylori eradication on GERD
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
Publications
Ceylan A, Kirimi E, Tuncer O, Turkdogan K, Ariyuca S, Ceylan N. Prevalence of Helicobacter pylori in children and their family members in a district in Turkey. J Health Popul Nutr. 2007 Dec;25(4):422-7.
PubMed 18402185
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Helicobacter Pylori Eradication on Gastroesophageal RefIux Disease (GERD)
- ClinicalTrials.gov ID
- NCT06457334
- Acronym / sponsor ID
- H.pylori eradication on GERD
- Conditions
- GERD
- Keywords
- Helicobacter pylori
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 13 Jun 2024 (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.
Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and symptoms improvement
Detailed description
HeIicobacter PyIori (H.pyIori) is a gram-negative spiral shaped bacterium that affects up to 50% of the population worldwide, with a higher prevalences in the developing countries,Gastroesophageal reflux disease (GERD) is a chronic gastrointestinal disorder characterized by the regurgitation of gastric contents into the esophagus, resulting in a significant economic burden in direct and indirect costs and adversely affects the quality of life.GERD is caused by multiple different mechanisms that can be intrinsic, structural, or both, leading to the disruption of the esophago-gastric junction barrier resulting in exposure of the esophagus to acidic gastric contents, Clinically, GERD typically manifests with symptoms of heartburn and regurgitation. It can also present in an atypical fashion with extra-esophageal symptoms such as chest pain, dental erosions, chronic cough, laryngitis, or asthma.The relationship between H. pylori and gastroesophageal reflux disease (GERD) is still unclear, and the effect of H. pylori eradication on GERD treatment is unknown.Several studies have shown the inverse relationship between the occurrence of GERD and H.pyIori infection, in particular an increased severity of the disease is documented in patients with pre-existing symptoms .It has been showed that a markedly resolution of dyspepsia in patients at whom the eradication therapy was successful when compared with subjects with a persistent infection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients diagnosed as GERD clinically and endscopically.
Key inclusion criteria (1 listed)
- All patients diagnosed as GERD clinically and endscopically.
Key exclusion criteria (1 listed)
- NO exclusion criteria
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
Eradication of Helicobacter pylori after triple therapy
Time frame: 1\2024 to 12\2024
H.pylori eradication will be assessed using the endoscope
Effect of Helicobacter pylori eradication on Gastroesophageal RefIux disease (GERD) syptomes
Time frame: 1\2024 to 12\2024
Evaluate the effect of H.pylori eradication on Gastroesophageal-reflux disease and correlate with GERD symptoms improvement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Background: PubMed 18402185Ceylan A, Kirimi E, Tuncer O, Turkdogan K, Ariyuca S, Ceylan N. Prevalence of Helicobacter pylori in children and their family members in a district in Turkey. J Health Popul Nutr. 2007 Dec;25(4):422-7.
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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. This study is not recruiting at the moment.
Saad Z Mahmoud, Professor study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara F Abdelhamid elgamal, master (+201023524835, sarafergany139@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication of Helicobacter pylori after triple therapy (time frame: 1\2024 to 12\2024). 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?
On the ClinicalTrials.gov record for NCT06457334, 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 13 Jun 2024.