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

Gastritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02806674
• Other study ID #: UHongKongShenzhen
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2016
• Last updated: October 29, 2017
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: October 2017
• Source: The University of Hong Kong-Shenzhen Hospital
• Contact: Tao Lyu, Doctor
• Email: lvt[@]hku-szh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1845
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastritis
• Helicobacter Infections

Intervention

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
• 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.

Locations

Country	Name	City	State
China	Longhua Branch of Shenzhen People Hospital	Shenzhen	Guangdong
China	People Hospital of Luohu,Shenzhen	Shenzhen	Guangdong
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	The People Hospital of Baoan Shenzhen	Shenzhen	Guangdong

Sponsors (6)

Lead Sponsor	Collaborator
The University of Hong Kong-Shenzhen Hospital	Longhua Branch of Shenzhen People Hospital, People Hospital of Luohu,Shenzhen, Shenzhen Second People's Hospital, The People Hospital of Baoan Shenzhen, Zhiyuan Medical Inspection Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	2.5 year
Secondary	The difference between microbial genes of different patients	By 2 or 3 metabolic pathways with significant differences, selected 40-50 different genes.	3 year
Secondary	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.	3 year