Helicobacter GastritisNCT04029441
The Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology
An observational study of Helicobacter Gastritis, run by Shandong University at 1 site in China.
Trial summary
Subjects who are included will recieve Hp eradication therapy based on antimicrobial susceptibility test. After the therapy, the subjects will be divided into two groups, the successful group and the failure group. And then they wiil be followed up to observe the development of the gastric mucosa pathology. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Gastritis
- What is being tested?
- the eradication Hp
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to 30 Sep 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included.
Who may be able to join
- Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.
Who cannot join
- Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, patients with peptic ulcer, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hosipital
Jinan, Shandong, 250012
Xiuli H Zuo, MD,PhD, 15588818685 ext. 0531-88369277, zuoxiuli@sdu.edu.cn
Tian H Ma, 18769781098 ext. 0531-88369277, matian1002@163.com
About this study
Official title: he Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology
Subjects who are included will recieve Hp eradication therapy based on antimicrobial susceptibility test. After the therapy, the subjects will be divided into two groups, the successful group and the failure group. And then they wiil be followed up to observe the development of the gastric mucosa pathology.
Read the detailed description
Subjects who are included will recieve Hp eradication therapy based on antimicrobial susceptibility test. After the therapy, the subjects will be divided into two groups, the successful group and the failure group. The subjects who fail to eradicate the Hp after initial treatment and rescue treatment will go into the failure group. Otherwhile, they will go to the successful group.And then they wiil be followed up to observe the development of the gastric mucosa pathology. For mild atrophy gastritis, non- intestinal metaplasial gastritis, follow-up is performed every 2-3 years.For severe atrophy gastritis, intestinal metaplasial gastritis, follow-up is performed every 1-2 years. For patients wth high-grade intraepithelial neoplasia, they can be included 3 months after the endoscopic treatment, and the follow up will be performed at 6, 12 months after the treatment and then the follow up will be carried out every 1 year. For non-atrophic gastritis, no follow-up will be performed. All included patients will recieve a follow-up at the endpoint of 5 years. The follow-up includes endoscopy examination and serum test of PG I,PG II and gastrin 17.
- Conditions
- Helicobacter Gastritis
- Being tested
- the eradication Hp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the eradication HpOther
the eradication of Hp based on antimicrobial susceptibility test
| Study group | Role | What they receive |
|---|---|---|
| the successful eradication cohort | the subjects who eradicate the Hp successfully after recieving the therapy or rescue therapy based on antimicrobial susceptibility test Receives: Other: the eradication Hp | |
| the failure eradication cohort | the subjects who fail to eradicate the Hp after recieving the therapy or rescue therapy based on antimicrobial susceptibility test |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pathologic status of mucosa
the development or change pathologic status of mucosa
Measured: 5 years
Secondary outcomes (3)
PG I
the serum level of PG I
Measured: 5 years
PG II
the serum level of PG II
Measured: 5 years
gastrin 17
the serum level of gastrin 17
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start1 Sep 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter GastritisStudies 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli H Zuo, Study chair, Qilu Hospital of Shandong UniversityTian H Ma, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029441
- Sponsor's protocol ID
- 2018SDU-QILU-G115
- Status last verified
- Jul 2019
- First submitted
- 21 Jul 2019
- Last updated
- 23 Jul 2019
- 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 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- he Effact of Helicobacter Hylori Eradication on the Development of Gastric Mucosa Pathology
- ClinicalTrials.gov ID
- NCT04029441
- Acronym / sponsor ID
- 2018SDU-QILU-G115
- Conditions
- Helicobacter Gastritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 23 Jul 2019 (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.
Subjects who are included will recieve Hp eradication therapy based on antimicrobial susceptibility test. After the therapy, the subjects will be divided into two groups, the successful group and the failure group. And then they wiil be followed up to observe the development of the gastric mucosa pathology.
Detailed description
Subjects who are included will recieve Hp eradication therapy based on antimicrobial susceptibility test. After the therapy, the subjects will be divided into two groups, the successful group and the failure group. The subjects who fail to eradicate the Hp after initial treatment and rescue treatment will go into the failure group. Otherwhile, they will go to the successful group.And then they wiil be followed up to observe the development of the gastric mucosa pathology. For mild atrophy gastritis, non- intestinal metaplasial gastritis, follow-up is performed every 2-3 years.For severe atrophy gastritis, intestinal metaplasial gastritis, follow-up is performed every 1-2 years. For patients wth high-grade intraepithelial neoplasia, they can be included 3 months after the endoscopic treatment, and the follow up will be performed at 6, 12 months after the treatment and then the follow up will be carried out every 1 year. For non-atrophic gastritis, no follow-up will be performed. All included patients will recieve a follow-up at the endpoint of 5 years. The follow-up includes endoscopy examination and serum test of PG I,PG II and gastrin 17.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the successful eradication cohort | – | Other: the eradication Hpthe subjects who eradicate the Hp successfully after recieving the therapy or rescue therapy based on antimicrobial susceptibility test |
| the failure eradication cohort | – | –the subjects who fail to eradicate the Hp after recieving the therapy or rescue therapy based on antimicrobial susceptibility test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included.
Key inclusion criteria (1 listed)
- Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.
Key exclusion criteria (1 listed)
- Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, patients with peptic ulcer, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
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 |
|---|---|---|
| the eradication Hpthe eradication of Hp based on antimicrobial susceptibility test | Other | the successful eradication cohort |
Primary outcome
the pathologic status of mucosa
Time frame: 5 years
the development or change pathologic status of mucosa
3 secondary outcomes
PG I
Time frame: 5 years
PG II
Time frame: 5 years
gastrin 17
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
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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.
Xiuli H Zuo study chair
Qilu Hospital of Shandong University
Tian H Ma principal investigator
Qilu Hospital of Shandong 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 Helicobacter Gastritis, run by Shandong 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 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 23 Jul 2019. 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 Xiuli H Zuo, MD,PhD (15588818685 ext. 053188369277, zuoxiuli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the pathologic status of mucosa (time frame: 5 years). 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 23 Jul 2019; AzTrials last refreshed its copy on 7 Nov 2026.