A Multi-center Study for Eradication of Refractory Helicobacter Pylori

Gastritis Clinical Trial

Official title:

Construction and Application of the Treatment of Refractory Helicobacter Pylori Infection Based on the High-throughput Sequencing Technologies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02741414
• Other study ID #: TaizhouH
• Status: Recruiting
• Phase: N/A
• First received: March 25, 2016
• Last updated: July 10, 2016
• Start date: June 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2016
• Source: Taizhou Hospital
• Contact: Liping Ye, BSc
• Phone: 13566866269
• Email: yelp[@]enzemed.com
• Is FDA regulated: No
• Health authority: China: Centers for Disease Control and Prevention
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4428
• Est. completion date: December 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastritis

Intervention

Device:
• The result of H pylori culture based on gram staining and enzyme activity testing
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 result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin,tetracycline,furazolidone and the dose of esomeprazole
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 result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing
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.

Locations

Country	Name	City	State
China	Xianju People Hospital	Taizhou	Zhejiang

Sponsors (16)

Lead Sponsor

Collaborator

Taizhou Hospital

Academy Military Medical Science, China, Centers for Disease Control and Prevention, China, First Affiliated Hospital of Zhejiang University, Sanmen People Hospital, Taizhou Central Hospital, Taizhou Enze Medical Center (Group) Enze Hospital, Taizhou Enze Medical Center (Group) Luqiao Hospital, The first people Hospital of Linhai, The first people Hospital of Taizhou, The first people Hospital of Wenling, The second people Hospital of Yuhuan, Tiantai People Hospital, Xianju People Hospital, Yuhuan People Hospital, Zhiyuan Medical Inspection Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The eradication rate of H. pylori reach to 95% in all groups		1 year	Yes
Primary	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	Yes
Primary	The proportion of mix infection of H pylori in a total of 240 patients in two groups		Three months	Yes
Primary	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	Yes