GastritisNCT02806674
A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection
A study testing The eradication times of the patients and The result of 13C-urea breath test after treatment in people with Gastritis, run by The University of Hong Kong-Shenzhen Hospital at 4 sites in China.
Trial summary
Approximately 50% of people in the world are infected with H. pylori, and its eradication rate fail to exceed 80% and even fails into an unacceptable range.Various risk factors for infection include lower socioeconomic status, younger age, and geographic location.In the present study, investigators aimed to perform a… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastritis
- What is being tested?
- The eradication times of the patients and The result of 13C-urea breath test after treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,845 participants
- Where
- 4 sitesChina
- Study dates
- Jul 2016to Dec 2019
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18~70 years old, male or female, untreated patients.
- Symptoms of abdominal pain, bloating, acid reflux,belching,nausea,vomiting,heartburn, chest pain, vomiting, melena, etc.
- Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks
- 13C-labelled urea breath test positive.
- Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
- Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.
Who cannot join
- Severe heart, liver, kidney dysfunction.
- Pregnant or lactating women.
- Complications of bleeding, perforation, pyloric obstruction, cancer.
- Esophageal,gastrointestinal surgery history.
- Patients can not properly express their complaints,such as psychosis, severe neurosis.
- Taking NSIAD or alcohol abusers.
- Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
Trial locations and contacts
4 sites in 1 country.
Tao Lyu, Doctor contact
China4 sites, 4 recruiting
- Recruiting
The People Hospital of Baoan Shenzhen
Shenzhen, Guangdong, 518100
Wei Jian Wu, 18938027180
- Recruiting
Longhua Branch of Shenzhen People Hospital
Shenzhen, Guangdong
Peng Yin Li, Doctor, 13670086396, szliyp72@126.com
- Recruiting
People Hospital of Luohu,Shenzhen
Shenzhen, Guangdong
Qiu Xi Yu, Doctor, 13714477392, yuer200470@126.com
- Recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong
Jun Liu, Master, liujunwenwne@163.com
Jian Hai Guo, Doctor, 13602641086, guohaijian@medmail.com
About this study
Approximately 50% of people in the world are infected with H. pylori, and its eradication rate fail to exceed 80% and even fails into an unacceptable range.Various risk factors for infection include lower socioeconomic status, younger age, and geographic location.In the present study, investigators aimed to perform a prevalence survey about risk factors for H. pylori infection.To obtain the higher eradication of H. pylori and find out the relevance between the diverse infection and clinical drug focused on refractory H. pylori infection.
- Conditions
- Gastritis
- Being tested
- The eradication times of the patients, The result of 13C-urea breath test after treatment
- Keywords
- Helicobacter pylori, Antibiotic resistance, Sequencing
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The eradication times of the patientsDevice
The patients who have failed more than 2 eradication courses with standardized treatment were the refractory infection of H. pylori group,and patients who succeeded at the first standardized treatment were the successful treatment group
The result of 13C-urea breath test after treatmentDevice
The intervention focused on the results from the result of 13C-urea breath test after treatment.The two groups were treatment based on the antibiotic susceptibility testing. Eight weeks after treatment,a 13C-urea breath test was performed on patients.The successful treatment group were patients with negative in 13C-urea breath tests in the first treatment. The refractory infection of H. pylori group were treatment failure patients after the second standardized treatment.
| Study group | Role | What they receive |
|---|---|---|
| Successful treatment | Experimental | Not described Receives: Device: The eradication times of the patients; Device: The result of 13C-urea breath test after treatment |
| Refractory infection of H.pylori | Experimental | Not described Receives: Device: The eradication times of the patients; Device: The result of 13C-urea breath test after treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication rate of H. pylori reach to 95%
The eradication rate of untreated cases reach to 98%.The eradication rate of refractory cases reach to 90%.
Measured: 1.5 year
Obtain the first resistant pattern to antibiotics in shenzhen area
The results of antibiotic susceptibility testing were analyzed in this study.More than 1800 patients were participated,these patients were representative in five hospitals of shenzhen area.
Measured: 1.5 year
The proportion of mix infection of H pylori in a total of 40 patients in two groups
Analyzed the next-generation sequencing data,obtain the proportion of mixed infection with different H. pylori strain in refractory cases.
Measured: 2.5 year
Secondary outcomes (3)
The incidence of adverse effects in the eradicate treatment
A telephone interview was conducted at 4 weeks after treatment.And the 1845 patients was investigated using questionnaires of symptom checklist.A statistics table will be got.
Measured: 2.5 year
The difference between microbial genes of different patients
By 2 or 3 metabolic pathways with significant differences, selected 40-50 different genes.
Measured: 3 year
The relevance between mixed infection, microflora structure and risk factors
Analyzed the next-generation sequencing data,obtain the results of mixed infection and microflora structure in a total of 40 patients in two groups.And the patients was investigated using questionnaires of risk checklist.The collected data were subsequently analyzed using SPSS. For checking the relationship between mixed infection, microflora structure and risk factors.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,845 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong-Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- People Hospital of Luohu,Shenzhen, Shenzhen Second People's Hospital, Longhua Branch of Shenzhen People Hospital, The People Hospital of Baoan Shenzhen, Zhiyuan Medical Inspection Institute
- Responsible party
- Principal investigator, TaoLYU, The University of Hong Kong-Shenzhen Hospital
- Investigators
- Tao Lyu, Doctor, Principal investigator, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02806674
- Sponsor's protocol ID
- UHongKongShenzhen
- Status last verified
- Oct 2017
- First submitted
- 9 Jun 2016
- Last updated
- 31 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT02806674
- Acronym / sponsor ID
- UHongKongShenzhen
- Conditions
- Gastritis
- Keywords
- Helicobacter pylori, Antibiotic resistance, Sequencing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,845 participants (estimated)
- Lead sponsor
- The University of Hong Kong-Shenzhen HospitalUniversity, hospital or other
- Collaborators
- People Hospital of Luohu,Shenzhen, Shenzhen Second People's Hospital, Longhua Branch of Shenzhen People Hospital, The People Hospital of Baoan Shenzhen, Zhiyuan Medical Inspection Institute
- Study start
- Jul 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Jun 2016 (estimated)
- 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.
Approximately 50% of people in the world are infected with H. pylori, and its eradication rate fail to exceed 80% and even fails into an unacceptable range.Various risk factors for infection include lower socioeconomic status, younger age, and geographic location.In the present study, investigators aimed to perform a prevalence survey about risk factors for H. pylori infection.To obtain the higher eradication of H. pylori and find out the relevance between the diverse infection and clinical drug focused on refractory H. pylori infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Successful treatment | Experimental | Device: The eradication times of the patients, Device: The result of 13C-urea breath test after treatment |
| Refractory infection of H.pylori | Experimental | Device: The eradication times of the patients, Device: The result of 13C-urea breath test after treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18~70 years old, male or female, untreated patients.
- Symptoms of abdominal pain, bloating, acid reflux,belching,nausea,vomiting,heartburn, chest pain, vomiting, melena, etc.
- Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks
- 13C-labelled urea breath test positive.
- Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
Key exclusion criteria (7 listed)
- Severe heart, liver, kidney dysfunction.
- Pregnant or lactating women.
- Complications of bleeding, perforation, pyloric obstruction, cancer.
- Esophageal,gastrointestinal surgery history.
- Patients can not properly express their complaints,such as psychosis, severe neurosis.
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 times of the patientsThe patients who have failed more than 2 eradication courses with standardized treatment were the refractory infection of H. pylori group,and patients who succeeded at the first standardized treatment were the successful treatment group | Device | Refractory infection of H.pylori, Successful treatment |
| The result of 13C-urea breath test after treatmentThe intervention focused on the results from the result of 13C-urea breath test after treatment.The two groups were treatment based on the antibiotic susceptibility testing. Eight weeks after treatment,a 13C-urea breath test was performed on patients.The successful treatment group were patients with negative in 13C-urea breath tests in the first treatment. The refractory infection of H. pylori group were treatment failure patients after the second standardized treatment. | Device | Refractory infection of H.pylori, Successful treatment |
Primary outcome
The eradication rate of H. pylori reach to 95%
Time frame: 1.5 year
The eradication rate of untreated cases reach to 98%.The eradication rate of refractory cases reach to 90%.
Obtain the first resistant pattern to antibiotics in shenzhen area
Time frame: 1.5 year
The results of antibiotic susceptibility testing were analyzed in this study.More than 1800 patients were participated,these patients were representative in five hospitals of shenzhen area.
The proportion of mix infection of H pylori in a total of 40 patients in two groups
Time frame: 2.5 year
Analyzed the next-generation sequencing data,obtain the proportion of mixed infection with different H. pylori strain in refractory cases.
3 secondary outcomes
The incidence of adverse effects in the eradicate treatment
Time frame: 2.5 year
The difference between microbial genes of different patients
Time frame: 3 year
The relevance between mixed infection, microflora structure and risk factors
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
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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.
Tao Lyu, Doctor contact
Tao Lyu, Doctor principal investigator
The University of Hong Kong-Shenzhen Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The eradication times of the patients and The result of 13C-urea breath test after treatment in people with Gastritis, run by The University of Hong Kong-Shenzhen Hospital at 4 sites 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 6 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: status not confirmed, as of the sponsor's last update on 31 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Tao Lyu, Doctor (lvt@hku-szh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The eradication rate of H. pylori reach to 95% (time frame: 1.5 year). The study lists 3 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 31 Oct 2017.