Helicobacter Pylori InfectionNCT05527496
Effect of Hp Infection on the Quality of Gastric Mucosa Preparation
An observational study of Helicobacter Pylori Infection, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
The purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Aug 2023
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All outpatients or inpatients requiring general gastroscopy
Who may be able to join
- Adults who volunteered to participate in this study and signed an informed consent form
- Have been tested for Helicobacter pylori and have definite test results
Who cannot join
- Contraindications for gastroscopy (such as severe cardiopulmonary diseases, liver and kidney dysfunction, shock, etc.)
- History of upper gastrointestinal surgery
- Therapeutic endoscopy and emergency surgery are required
- Recent history of upper gastrointestinal bleeding
- Corrosive substance ingestion
- The pregnancy
- Abnormal mental state cannot cooperate with the examination
- Patients with contraindications to the drugs used in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710000
Na Liu, 18629082319, liunafmmu@163.com
About this study
Official title: Effect of Hp Infection on the Quality of Gastric Mucosa Preparation and Study on Different Gastric Mucosa Preparation Schemes in Patients With Hp Infection
The purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation.
Read the detailed description
The purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation by comparing the cleanliness of gastric mucosa between patients with Helicobacter pylori infection and those without Helicobacter pylori infection.
- Conditions
- Helicobacter Pylori Infection
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 |
|---|---|---|
| Patients with Helicobacter pylori infection | Patients with H. pylori infection identified by testing for H. pylori. | |
| Patients not infected with Helicobacter pylori | Patients without H. pylori infection identified by H. pylori testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cleanliness of gastric mucosa
The visibility of gastric mucosa was scored for four parts of the stomach (antrum, upper body, lower body and fundus).
Measured: The time the patient underwent gastroscopy procedure
Secondary outcomes (4)
Time to complete gastroscopy
The time from the start of the endoscopy to the complete removal of the endoscope
Measured: The day of gastroscopy
Patient comfort score
Prior to endoscopy, the patient was instructed to indicate the level of discomfort on a visual analogue scale, which was rated by the patient on a scale of 0 to 10, with 0 indicating no discomfort and 10 indicating maximum discomfort.
Measured: Records were made on the 1 day of the gastroscopy
adverse reaction
Adverse reactions to study drugs, and respiratory, cardiovascular, or endoscopic adverse events.
Measured: Within 24 hours after endoscopy
Endoscopic findings
The diagnostic results were recorded under gastroscopy, and if the biopsy was taken under gastroscopy, the pathological results were also recorded
Measured: About 15 days after endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start1 Aug 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion31 Aug 2023 (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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527496
- Sponsor's protocol ID
- individualliu
- Status last verified
- Sep 2022
- First submitted
- 31 Aug 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hp Infection on the Quality of Gastric Mucosa Preparation and Study on Different Gastric Mucosa Preparation Schemes in Patients With Hp Infection
- ClinicalTrials.gov ID
- NCT05527496
- Acronym / sponsor ID
- individualliu
- Conditions
- Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 2 Sep 2022 (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 purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation.
Detailed description
The purpose of this study was to evaluate the effect of Helicobacter pylori infection on the quality of gastric mucosa preparation by comparing the cleanliness of gastric mucosa between patients with Helicobacter pylori infection and those without Helicobacter pylori infection.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Helicobacter pylori infection | – | –Patients with H. pylori infection identified by testing for H. pylori. |
| Patients not infected with Helicobacter pylori | – | –Patients without H. pylori infection identified by H. pylori testing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All outpatients or inpatients requiring general gastroscopy
Key inclusion criteria (2 listed)
- Adults who volunteered to participate in this study and signed an informed consent form
- Have been tested for Helicobacter pylori and have definite test results
Key exclusion criteria (8 listed)
- Contraindications for gastroscopy (such as severe cardiopulmonary diseases, liver and kidney dysfunction, shock, etc.)
- History of upper gastrointestinal surgery
- Therapeutic endoscopy and emergency surgery are required
- Recent history of upper gastrointestinal bleeding
- Corrosive substance ingestion
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
Cleanliness of gastric mucosa
Time frame: The time the patient underwent gastroscopy procedure
The visibility of gastric mucosa was scored for four parts of the stomach (antrum, upper body, lower body and fundus).
4 secondary outcomes
Time to complete gastroscopy
Time frame: The day of gastroscopy
Patient comfort score
Time frame: Records were made on the 1 day of the gastroscopy
adverse reaction
Time frame: Within 24 hours after endoscopy
Endoscopic findings
Time frame: About 15 days after endoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
- Individual participant dataSharing planned: No
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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.
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 Helicobacter Pylori Infection, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
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 8 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 2 Sep 2022. 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 China. 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 Na Liu (18629082319, liunafmmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cleanliness of gastric mucosa (time frame: The time the patient underwent gastroscopy procedure). 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 2 Sep 2022.