Clinical trial NCT02741414: A Multi-center Study for Eradication of Refractory Helicobacter Pylori
Official title: Construction and Application of the Treatment of Refractory Helicobacter Pylori Infection Based on the High-throughput Sequencing Technologies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastritis
Keywords: Helicobacter pylori
Antibiotic resistance
Sequencing
Mechanism
Lead sponsor: Taizhou Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention, China
name: Academy Military Medical Science, China
name: First Affiliated Hospital of Zhejiang University
name: Taizhou Enze Medical Center Group
name: Taizhou First People's Hospital
name: The first people Hospital of Linhai
name: Affiliated Wenling Hospital of Wenzhou Medical University
name: Sanmen People Hospital
name: Xianju People Hospital
name: Tiantai People Hospital
name: Yuhuan People Hospital
name: The second people Hospital of Yuhuan
name: Zhiyuan Medical Inspection Institute
First posted: 2016-04-18
Enrollment: 4428
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age 18\~70 years old, male or female, the first eradication therapy of H. pylori infection patients.
2. Symptoms of abdominal pain, bloating, acid efflux, belching, nausea, vomiting, heartburn, chest pain, vomiting, melena, etc.
3. Unused antibiotics, bismuth, H2 receptor antagonists or PPIs by nearly 4 weeks
4. 13C-labelled urea breath test positive.
5. Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive.
6. Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey.

Exclusion Criteria:

1. Severe heart, liver, kidney dysfunction.
2. Pregnant or lactating women.
3. Complications of bleeding, perforation, pyloric obstruction, cancer.
4. Esophageal,gastrointestinal surgery history.
5. Patients can not properly express their complaints,such as psychosis, severe neurosis.
6. Taking nonsteroidal antiinflammatory drugs (NSAIDs) or alcohol abusers.
7. Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.

Primary outcomes:
measure: The eradication rate of H. pylori reach to 95% in all groups
timeFrame: 1 year
measure: The microflora structure of a total of 240 patients in the first successful eradication group and the refractory infection of H. pylori group
timeFrame: Three months
measure: The proportion of mix infection of H pylori in a total of 240 patients in two groups
timeFrame: Three months
measure: 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
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Taizhou
country: China
facility: Xianju People Hospital
state: Zhejiang
Study officials:
References: