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

Not Applicable

• Conditions: Gastritis
• Interventions: Device: The eradication times of the patients; Device: The result of 13C-urea breath test after treatment

• Registration Number: NCT02806674
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-21
• Study Start: 2016-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-29
• Last Update Posted: 2017-10-31
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1845

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Successful treatment	The eradication times of the patients	-
Refractory infection of H.pylori	The eradication times of the patients	-
Refractory infection of H.pylori	The result of 13C-urea breath test after treatment	-
Successful treatment	The result of 13C-urea breath test after treatment	-

Primary Outcome Measures

Name	Time	Method
The eradication rate of H. pylori reach to 95%	1.5 year	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	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.
The proportion of mix infection of H pylori in a total of 40 patients in two groups	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

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

Trial Locations

Locations (4)

The People Hospital of Baoan Shenzhen; 🇨🇳 Shenzhen, Guangdong, China

People Hospital of Luohu,Shenzhen; 🇨🇳 Shenzhen, Guangdong, China

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, Guangdong, China

Longhua Branch of Shenzhen People Hospital; 🇨🇳 Shenzhen, Guangdong, China