Clinical trial NCT02806674: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gastritis
Keywords: Helicobacter pylori
Antibiotic resistance
Sequencing
Lead sponsor: The University of Hong Kong-Shenzhen Hospital
Sponsor class: OTHER
Collaborators: name: People Hospital of Luohu,Shenzhen
name: Shenzhen Second People's Hospital
name: Longhua Branch of Shenzhen People Hospital
name: The People Hospital of Baoan Shenzhen
name: Zhiyuan Medical Inspection Institute
First posted: 2016-06-21
Enrollment: 1845
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The eradication rate of H. pylori reach to 95%
timeFrame: 1.5 year
measure: Obtain the first resistant pattern to antibiotics in shenzhen area
timeFrame: 1.5 year
measure: The proportion of mix infection of H pylori in a total of 40 patients in two groups
timeFrame: 2.5 year
Secondary outcomes:
measure: The incidence of adverse effects in the eradicate treatment
timeFrame: 2.5 year
measure: The difference between microbial genes of different patients
timeFrame: 3 year
measure: The relevance between mixed infection, microflora structure and risk factors
timeFrame: 3 year
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: The People Hospital of Baoan Shenzhen
state: Guangdong
city: Shenzhen
country: China
facility: Longhua Branch of Shenzhen People Hospital
state: Guangdong
city: Shenzhen
country: China
facility: People Hospital of Luohu,Shenzhen
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital
state: Guangdong
Study officials:
affiliation: The University of HongKong-Shenzhen Hospital
name: Tao Lyu, Doctor
role: PRINCIPAL_INVESTIGATOR
References: