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A Multi-center Study for Eradication of Refractory Helicobacter Pylori

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ClinicalTrials.gov Identifier: NCT02741414
Recruitment Status : Unknown
Verified March 2016 by Liping Ye, Taizhou Hospital.
Recruitment status was:  Recruiting
First Posted : April 18, 2016
Last Update Posted : July 12, 2016
Sponsor:
Collaborators:
Centers for Disease Control and Prevention, China
Academy Military Medical Science, China
Taizhou Central Hospital
First Affiliated Hospital of Zhejiang University
Taizhou Enze Medical Center (Group) Luqiao Hospital
Taizhou Enze Medical Center (Group) Enze Hospital
The first people Hospital of Taizhou
The first people Hospital of Linhai
The first people Hospital of Wenling
Sanmen People Hospital
Xianju People Hospital
Tiantai People Hospital
Yuhuan People Hospital
The second people Hospital of Yuhuan
Zhiyuan Medical Inspection Institute
Information provided by (Responsible Party):
Liping Ye, Taizhou Hospital

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.

Condition or disease Intervention/treatment Phase
Gastritis Device: The result of H pylori culture based on gram staining and enzyme activity testing Device: 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 Device: The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4428 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Construction and Application of the Treatment of Refractory Helicobacter Pylori Infection Based on the High-throughput Sequencing Technologies
Study Start Date : June 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: H pylori culture negative group
The patients who have the negative result of H pylori culture were classified into H pylori culture negative group.
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.

Experimental: The first successful eradication group
The 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.
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.

Device: 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.

Device: 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.

Experimental: The refractory infection of H. pylori group
The 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.
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.

Device: 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.

Device: 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.




Primary Outcome Measures :
  1. The eradication rate of H. pylori reach to 95% in all groups [ Time Frame: 1 year ]
  2. The microflora structure of a total of 240 patients in the first successful eradication group and the refractory infection of H. pylori group [ Time Frame: Three months ]
  3. The proportion of mix infection of H pylori in a total of 240 patients in two groups [ Time Frame: Three months ]
  4. 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 [ Time Frame: Three months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741414


Contacts
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Contact: Liping Ye, BSc 13566866269 yelp@enzemed.com

Locations
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China, Zhejiang
Xianju People Hospital Recruiting
Taizhou, Zhejiang, China, 317300
Contact: Hong Li Lyh    13586202668      
Sponsors and Collaborators
Taizhou Hospital
Centers for Disease Control and Prevention, China
Academy Military Medical Science, China
Taizhou Central Hospital
First Affiliated Hospital of Zhejiang University
Taizhou Enze Medical Center (Group) Luqiao Hospital
Taizhou Enze Medical Center (Group) Enze Hospital
The first people Hospital of Taizhou
The first people Hospital of Linhai
The first people Hospital of Wenling
Sanmen People Hospital
Xianju People Hospital
Tiantai People Hospital
Yuhuan People Hospital
The second people Hospital of Yuhuan
Zhiyuan Medical Inspection Institute

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Responsible Party: Liping Ye, Director of the Department of Gastroenterology, Taizhou Hospital
ClinicalTrials.gov Identifier: NCT02741414     History of Changes
Other Study ID Numbers: TaizhouH
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: March 2016

Keywords provided by Liping Ye, Taizhou Hospital:
Helicobacter pylori
Antibiotic resistance
Sequencing
Mechanism

Additional relevant MeSH terms:
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Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Bacterial Agents
Amoxicillin
Metronidazole
Clarithromycin
Levofloxacin
Ofloxacin
Tetracycline
Antibiotics, Antitubercular
Furazolidone
Esomeprazole
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Topoisomerase II Inhibitors