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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

Primary Purpose

Gastritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The eradication times of the patients
The result of 13C-urea breath test after treatment
Sponsored by
The University of Hong Kong-Shenzhen Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastritis focused on measuring Helicobacter pylori, Antibiotic resistance, Sequencing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The People Hospital of Baoan ShenzhenRecruiting
  • Longhua Branch of Shenzhen People HospitalRecruiting
  • People Hospital of Luohu,ShenzhenRecruiting
  • Shenzhen Second People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Successful treatment

Refractory infection of H.pylori

Arm Description

Outcomes

Primary Outcome Measures

The eradication rate of H. pylori reach to 95%
The eradication rate of untreated cases reach to 98%.The eradication rate of refractory cases reach to 90%.
Obtain the first resistant pattern to antibiotics in shenzhen area
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.
The proportion of mix infection of H pylori in a total of 40 patients in two groups
Analyzed the next-generation sequencing data,obtain the proportion of mixed infection with different H. pylori strain in refractory cases.

Secondary Outcome Measures

The incidence of adverse effects in the eradicate treatment
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.
The difference between microbial genes of different patients
By 2 or 3 metabolic pathways with significant differences, selected 40-50 different genes.
The relevance between mixed infection, microflora structure and risk factors
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.

Full Information

First Posted
June 9, 2016
Last Updated
October 29, 2017
Sponsor
The University of Hong Kong-Shenzhen Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT02806674
Brief Title
A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection
Official Title
A Relevance Study Between the Result of Clinical Drug Intervention and Next-generation Sequencing Technology Focused on Refractory Helicobacter Pylori Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong-Shenzhen Hospital
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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastritis
Keywords
Helicobacter pylori, Antibiotic resistance, Sequencing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1845 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Successful treatment
Arm Type
Experimental
Arm Title
Refractory infection of H.pylori
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
The eradication times of the patients
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
The result of 13C-urea breath test after treatment
Intervention Description
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 Measure Information:
Title
The eradication rate of H. pylori reach to 95%
Description
The eradication rate of untreated cases reach to 98%.The eradication rate of refractory cases reach to 90%.
Time Frame
1.5 year
Title
Obtain the first resistant pattern to antibiotics in shenzhen area
Description
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.
Time Frame
1.5 year
Title
The proportion of mix infection of H pylori in a total of 40 patients in two groups
Description
Analyzed the next-generation sequencing data,obtain the proportion of mixed infection with different H. pylori strain in refractory cases.
Time Frame
2.5 year
Secondary Outcome Measure Information:
Title
The incidence of adverse effects in the eradicate treatment
Description
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.
Time Frame
2.5 year
Title
The difference between microbial genes of different patients
Description
By 2 or 3 metabolic pathways with significant differences, selected 40-50 different genes.
Time Frame
3 year
Title
The relevance between mixed infection, microflora structure and risk factors
Description
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.
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18~70 years old, male or female, untreated patients. Symptoms of abdominal pain, bloating, acid reflux,belching,nausea,vomiting,heartburn, chest pain, vomiting, melena, etc. Unused antibiotics, bismuth, H2 receptor antagonists or PPI by nearly 4 weeks 13C-labelled urea breath test positive. Agreed to Helicobacter pylori culture and sensitivity testing taken by endoscopy gastric biopsy specimens,and the result of culture was positive. Agreed to Helicobacter pylori eradication therapy and cooperate with the eradication efficacy follow-up survey. Exclusion Criteria: Severe heart, liver, kidney dysfunction. Pregnant or lactating women. Complications of bleeding, perforation, pyloric obstruction, cancer. Esophageal,gastrointestinal surgery history. Patients can not properly express their complaints,such as psychosis, severe neurosis. Taking NSIAD or alcohol abusers. Allergic to penicillin or either drugs of the 6 antibiotic tested by susceptibility testing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Lyu, Doctor
Email
lvt@hku-szh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tao Lyu, Doctor
Organizational Affiliation
The University of HongKong-Shenzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The People Hospital of Baoan Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Jian Wu
Phone
18938027180
Facility Name
Longhua Branch of Shenzhen People Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peng Yin Li, Doctor
Phone
13670086396
Email
szliyp72@126.com
Facility Name
People Hospital of Luohu,Shenzhen
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiu Xi Yu, Doctor
Phone
13714477392
Email
yuer200470@126.com
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Liu, Master
Email
liujunwenwne@163.com
First Name & Middle Initial & Last Name & Degree
Jian Hai Guo, Doctor
Phone
13602641086
Email
guohaijian@medmail.com

12. IPD Sharing Statement

Learn more about this trial

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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