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

NCT02806674 | Unknown

• 1 other identifier: UHongKongShenzhen
• Study Type: interventional
• Target: 1,845
• Locations: 1 country
• Sites: 4

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.

Conditions

Gastritis

Keywords

Helicobacter pylori; Antibiotic resistance; Sequencing

Outcome Measures

Primary Outcomes (3)

• 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%.

  1.5 year

• 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.

  1.5 year

• 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.

  2.5 year

Secondary Outcomes (3)

• The incidence of adverse effects in the eradicate treatment

  2.5 year

• The difference between microbial genes of different patients

  3 year

• The relevance between mixed infection, microflora structure and risk factors

  3 year

Study Arms (2)

Successful treatment

EXPERIMENTAL

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

Refractory infection of H.pylori

EXPERIMENTAL

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

Interventions

The eradication times of the patients DEVICE

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

Refractory infection of H.pylori; Successful treatment

The result of 13C-urea breath test after treatment DEVICE

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.

Refractory infection of H.pylori; Successful treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• C-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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong-Shenzhen Hospital: lead
• People Hospital of Luohu,Shenzhen: collaborator
• Shenzhen Second People's Hospital: collaborator
• Longhua Branch of Shenzhen People Hospital: collaborator
• The People Hospital of Baoan Shenzhen: collaborator
• Zhiyuan Medical Inspection Institute: collaborator

Study Sites (4)

The People Hospital of Baoan Shenzhen

Shenzhen, Guangdong, 518100, China

RECRUITING

Longhua Branch of Shenzhen People Hospital

Shenzhen, Guangdong, China

RECRUITING

People Hospital of Luohu,Shenzhen

Shenzhen, Guangdong, China

RECRUITING

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Gastritis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Officials

• Tao Lyu, Doctor

  The University of HongKong-Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Lyu, Doctor

CONTACT

lvt@hku-szh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of the Department of Gastroenterology

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 21, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

CN (4)