Gastritis H PyloriNCT06015763
Correlation Between H.Pylori Colonization and Gastritis
A study testing Endoscopy in people with Gastritis H Pylori, run by Merna Mawgoud Zaki Bechit.
Trial summary
To study the prevelance rate of H.pylori colonization in patients with gastritis. To correlate the H.pylori colonization with endoscopic finding. To correlate both H.pylori colonization and endoscopic finding with clinical manifestation. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastritis H Pylori
- What is being tested?
- Endoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Dec 2024
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients with gastritis above 18 years old with chronic H.pylori infection documented by histological examination included in the study.
Who cannot join
- All patients mentioned above who have previous gastrointestinal surgery and patients below 18y .
Trial locations and contacts
No sites are listed yet.
Fatema Abu-Bakr contact
About this study
Official title: Correlation Between H.Pylori Colonization and Severity of Gastritis
To study the prevelance rate of H.pylori colonization in patients with gastritis.
To correlate the H.pylori colonization with endoscopic finding. To correlate both H.pylori colonization and endoscopic finding with clinical manifestation.
Read the detailed description
Helicobacter pylori is a gram negative microaerophilic spiral bacterium that is usually found in the stomach and thereby cause infection , which is associated with varying degrees of damage of superficial and glandular epithelium.
Chronic gastritis is a histological entity that is defined by an inflammatory infiltrate of lymphoblasma cells, cocsometimes polynuclear neutrophils and by progressive glandular atrophy of the gastric mucosa,and probably the main cause of chronic inflammation in the gastric mucosa which is usually caused by H.pylori infection.
In addition to chronic gastritis almost all benign gastroduodenal diseases including peptic ulcer , mucosa associated lymphoid tissue lymphoma and malignant gastroduodenal adenocarcinoma occurs due to previous H.pylori infection that is usually started with gastric precancerous lesion, gastric atrophy , gastric intestinal metaplasia , dysplasia and then turned to gastric carcinoma.
So the evaluation of H.pylori infection status yo non-infection, past infection, current infection by endoscopy has therefore become increasingly important.
The Sydney grading system is one of the most important recognised tools yo charactize histological lesions of chronic gastritis.
The system categorise gastritis according to intensity of mononuclear inflammatory cellular infiltrate , polymorph activity , atrophy , intestinal metaplasia and H.pylori density into mild , moderate and severe categories, but up till now there is non-standard histology reporting formats are still widely used for gastritis and even specialists are often frustrated by the histological definition that make it difficult to identify candidates for clinico-endoscopic surveillance.
Therefore the eradication of this bacterium aimed to interrupt the carcinogenesis process and prevent recurrence of gastritis and peptic ulcer disease.
However despite of the significant researches conducted on H.pylori colonization in gastric mucosa and its association with endoscopic finding and severity of clinical manifestations, and its impact on the Egyptian population is still a topic of debate.
Currently, there is no study has definitively determined this relationship in the Egyptian population despite the high prevalence rate of H.pylori infection
- Conditions
- Gastritis H Pylori
- Being tested
- Endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoscopyProcedure or surgery
Endoscopic biopsy
| Study group | Role | What they receive |
|---|---|---|
| Relation between gastritis and H.pylori | Other | Endoscopic Receives: Procedure: Endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between H.pylori colonization and severity of gastritis.
Biopsy will be taken to correlate between severity of gastritis and colonization of H.pylori.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastritis H PyloriStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Endoscopic
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merna Mawgoud Zaki Bechit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merna Mawgoud Zaki Bechit, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015763
- Sponsor's protocol ID
- H.pylori and gastritis
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between H.Pylori Colonization and Severity of Gastritis
- ClinicalTrials.gov ID
- NCT06015763
- Acronym / sponsor ID
- H.pylori and gastritis
- Conditions
- Gastritis H Pylori
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Merna Mawgoud Zaki BechitUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Aug 2023 (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.
To study the prevelance rate of H.pylori colonization in patients with gastritis.
To correlate the H.pylori colonization with endoscopic finding. To correlate both H.pylori colonization and endoscopic finding with clinical manifestation.
Detailed description
Helicobacter pylori is a gram negative microaerophilic spiral bacterium that is usually found in the stomach and thereby cause infection , which is associated with varying degrees of damage of superficial and glandular epithelium.
Chronic gastritis is a histological entity that is defined by an inflammatory infiltrate of lymphoblasma cells, cocsometimes polynuclear neutrophils and by progressive glandular atrophy of the gastric mucosa,and probably the main cause of chronic inflammation in the gastric mucosa which is usually caused by H.pylori infection.
In addition to chronic gastritis almost all benign gastroduodenal diseases including peptic ulcer , mucosa associated lymphoid tissue lymphoma and malignant gastroduodenal adenocarcinoma occurs due to previous H.pylori infection that is usually started with gastric precancerous lesion, gastric atrophy , gastric intestinal metaplasia , dysplasia and then turned to gastric carcinoma.
So the evaluation of H.pylori infection status yo non-infection, past infection, current infection by endoscopy has therefore become increasingly important.
The Sydney grading system is one of the most important recognised tools yo charactize histological lesions of chronic gastritis.
The system categorise gastritis according to intensity of mononuclear inflammatory cellular infiltrate , polymorph activity , atrophy , intestinal metaplasia and H.pylori density into mild , moderate and severe categories, but up till now there is non-standard histology reporting formats are still widely used for gastritis and even specialists are often frustrated by the histological definition that make it difficult to identify candidates for clinico-endoscopic surveillance.
Therefore the eradication of this bacterium aimed to interrupt the carcinogenesis process and prevent recurrence of gastritis and peptic ulcer disease.
However despite of the significant researches conducted on H.pylori colonization in gastric mucosa and its association with endoscopic finding and severity of clinical manifestations, and its impact on the Egyptian population is still a topic of debate.
Currently, there is no study has definitively determined this relationship in the Egyptian population despite the high prevalence rate of H.pylori infection
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Endoscopic
| Arm | Type | Receives |
|---|---|---|
| Relation between gastritis and H.pylori | Other | Procedure: EndoscopyEndoscopic |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with gastritis above 18 years old with chronic H.pylori infection documented by histological examination included in the study.
Key exclusion criteria (1 listed)
- All patients mentioned above who have previous gastrointestinal surgery and patients below 18y .
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 |
|---|---|---|
| EndoscopyEndoscopic biopsy | Procedure or surgery | Relation between gastritis and H.pylori |
Primary outcome
Correlation between H.pylori colonization and severity of gastritis.
Time frame: Baseline
Biopsy will be taken to correlate between severity of gastritis and colonization of H.pylori.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
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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.
Fatema Abu-Bakr contact
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy in people with Gastritis H Pylori, run by Merna Mawgoud Zaki Bechit.
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 29 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merna Mawgoud (01282213004, mernamawgoud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between H.pylori colonization and severity of gastritis. (time frame: Baseline). 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 29 Aug 2023.