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

October 29, 2017 updated by: TaoLYU, The University of Hong Kong-Shenzhen Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1845

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China
      • Shenzhen, Guangdong, China, 518100
        • Recruiting
        • The People Hospital of Baoan Shenzhen
        • Contact:
          • Wei Jian Wu
          • Phone Number: 18938027180
      • Shenzhen, Guangdong, China
        • Recruiting
        • Longhua Branch of Shenzhen People Hospital
        • Contact:
      • Shenzhen, Guangdong, China
        • Recruiting
        • People Hospital of Luohu,Shenzhen
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
1.5 year
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.
1.5 year
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.
2.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2.5 year
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 year
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.
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong-Shenzhen Hospital

Collaborators

Shenzhen Second People's Hospital
The People Hospital of Baoan Shenzhen
People Hospital of Luohu,Shenzhen
Longhua Branch of Shenzhen People Hospital
Zhiyuan Medical Inspection Institute

Investigators

  • Principal Investigator: Tao Lyu, Doctor, The University of HongKong-Shenzhen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 20, 2016

First Posted (ESTIMATE)

June 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2017

Last Update Submitted That Met QC Criteria

October 29, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHongKongShenzhen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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