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A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT02806674
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : October 31, 2017
Sponsor:
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
Information provided by (Responsible Party):
TaoLYU, The University of Hong Kong-Shenzhen Hospital

Brief 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 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.

Condition or disease Intervention/treatment Phase
Gastritis Device: The eradication times of the patients Device: The result of 13C-urea breath test after treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1845 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection
Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Successful treatment Device: The eradication times of the patients
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

Device: The result of 13C-urea breath test after treatment
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.

Experimental: Refractory infection of H.pylori Device: The eradication times of the patients
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

Device: The result of 13C-urea breath test after treatment
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.




Primary Outcome Measures :
  1. 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%.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. The incidence of adverse effects in the eradicate treatment [ Time Frame: 2.5 year ]
    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.

  2. The difference between microbial genes of different patients [ Time Frame: 3 year ]
    By 2 or 3 metabolic pathways with significant differences, selected 40-50 different genes.

  3. The relevance between mixed infection, microflora structure and risk factors [ Time Frame: 3 year ]
    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.



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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, untreated patients.
  2. Symptoms of abdominal pain, bloating, acid reflux,belching,nausea,vomiting,heartburn, chest pain, vomiting, melena, etc.
  3. Unused antibiotics, bismuth, H2 receptor antagonists or PPI 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 NSIAD 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): NCT02806674


Contacts
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Contact: Tao Lyu, Doctor lvt@hku-szh.org

Locations
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China, Guangdong
The People Hospital of Baoan Shenzhen Recruiting
Shenzhen, Guangdong, China, 518100
Contact: Wei Jian Wu    18938027180      
Longhua Branch of Shenzhen People Hospital Recruiting
Shenzhen, Guangdong, China
Contact: Peng Yin Li, Doctor    13670086396    szliyp72@126.com   
People Hospital of Luohu,Shenzhen Recruiting
Shenzhen, Guangdong, China
Contact: Qiu Xi Yu, Doctor    13714477392    yuer200470@126.com   
Shenzhen Second People's Hospital Recruiting
Shenzhen, Guangdong, China
Contact: Jun Liu, Master       liujunwenwne@163.com   
Contact: Jian Hai Guo, Doctor    13602641086    guohaijian@medmail.com   
Sponsors and Collaborators
The University of Hong Kong-Shenzhen Hospital
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
Investigators
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Principal Investigator: Tao Lyu, Doctor The University of HongKong-Shenzhen Hospital

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Responsible Party: TaoLYU, Deputy Director of the Department of Gastroenterology, The University of Hong Kong-Shenzhen Hospital
ClinicalTrials.gov Identifier: NCT02806674     History of Changes
Other Study ID Numbers: UHongKongShenzhen
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Keywords provided by TaoLYU, The University of Hong Kong-Shenzhen Hospital:
Helicobacter pylori
Antibiotic resistance
Sequencing

Additional relevant MeSH terms:
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Helicobacter Infections
Gastritis
Gram-Negative Bacterial Infections
Bacterial Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases