A Multi-center Study for Eradication of Refractory Helicobacter Pylori
Construction and Application of the Treatment of Refractory Helicobacter Pylori Infection Based on the High-throughput Sequencing Technologies
1 other identifier
interventional
4,428
1 country
1
Brief Summary
Recently studies showed that the eradication rate of H. pylori fail to exceed 80% and even falls into an unacceptable range. A major cause of treatment failure is associated with antibiotic resistance and poor patient compliance. However, the refractory infection of H. pylori is still existing, although patients have good compliance and receive standardized treatment. This phenomenon is likely attributed to the different ratio of sensitive and resistance in H. pylori, the difference of Amoxicillin resistance between in vivo and in vitro, the difference between phenotype and genotype or the influence of micro-environment in the stomach. In order to solve the refractory infection of H. pylori, investigators performed a muti-center study together with other 14 institutions. In this study, investigators will select the patients with refractory infection of H. pylori after two standardized treatment from patients with first eradication therapy of H. pylori infection. Then, investigators will perform a high-throughput sequencing for patients in groups. Finally, investigators will compare the differences between the patients with first successful eradication and patients with refractory infection of H. pylori, such as drug resistance gene mutation, phenotype and genotype, the mechanisms of Amoxicillin resistance and micro-environment in stomach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 12, 2016
March 1, 2016
1.8 years
March 25, 2016
July 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The eradication rate of H. pylori reach to 95% in all groups
1 year
The microflora structure of a total of 240 patients in the first successful eradication group and the refractory infection of H. pylori group
Three months
The proportion of mix infection of H pylori in a total of 240 patients in two groups
Three months
The number of single nucleotide varation（SNV）of 20 patients in the first successful eradication group and the refractory infection of H. pylori group that are related to Amoxicillin resistance
Three months
Study Arms (3)
H pylori culture negative group
EXPERIMENTALThe patients who have the negative result of H pylori culture were classified into H pylori culture negative group.
The first successful eradication group
EXPERIMENTALThe patients with first eradication therapy of H. pylori infection have the first successful treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and proton pump inhibitors （PPIs) dose selection from CYP2C19 gene sequencing.
The refractory infection of H. pylori group
EXPERIMENTALThe patients with first eradication therapy of H. pylori infection have the two failure treatment based on the standardized treatment including antibiotics selection from antibiotic susceptibility testing and PPIs dose selection from CYP2C19 gene sequencing.
Interventions
This intervention aimed at patients with the positive result of 13C-urea breath test. Patients with negative result of H pylori culture was H pylori culture negative group. Patients with positive result of H pylori culture were belonged into the first successful eradication group and the refractory infection of H. pylori group.
The intervention focused on the results from the result of 13C-urea breath test after treatment. The first successful eradication group and the refractory infection of H. pylori group were treated according to the antibiotic susceptibility testing and CYP2C19 gene polymorphism. Eight weeks after treatment, a 13C-urea breath test was performed on patients. The first successful eradication 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 with positive in 13C-urea breath tests after the second standardized treatment.
The intervention focused on the results from the result of Amoxicillin susceptibility testing in vitro. In this study, the investigators selected the patients with Amoxicillin resistance from the first successful eradication group and the refractory infection of H. pylori group.
Eligibility Criteria
You may qualify if:
- Age 18\~70 years old, male or female, the first eradication therapy of H. pylori infection patients.
- Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
- Unused antibiotics, bismuth, H2 receptor antagonists or PPIs by nearly 4 weeks
- C-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.
You may not qualify if:
- 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 nonsteroidal antiinflammatory drugs (NSAIDs) or alcohol abusers.
- Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Taizhou Hospitallead
- Centers for Disease Control and Prevention, Chinacollaborator
- Academy Military Medical Science, Chinacollaborator
- First Affiliated Hospital of Zhejiang Universitycollaborator
- Taizhou Enze Medical Center Groupcollaborator
- Taizhou First People's Hospitalcollaborator
- The first people Hospital of Linhaicollaborator
- Affiliated Wenling Hospital of Wenzhou Medical Universitycollaborator
- Sanmen People Hospitalcollaborator
- Xianju People Hospitalcollaborator
- Tiantai People Hospitalcollaborator
- Yuhuan People Hospitalcollaborator
- The second people Hospital of Yuhuancollaborator
- Zhiyuan Medical Inspection Institutecollaborator
Study Sites (1)
Xianju People Hospital
Taizhou, Zhejiang, 317300, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Department of Gastroenterology
Study Record Dates
First Submitted
March 25, 2016
First Posted
April 18, 2016
Study Start
June 1, 2016
Primary Completion
April 1, 2018
Study Completion
December 1, 2018
Last Updated
July 12, 2016
Record last verified: 2016-03