A Multi-center Study for Individual Treatment of Helicobacter Pylori Infection

Not Applicable

• Conditions: Gastritis; Gastric Ulcer
• Interventions: Biological: Antibiotic selection based on the antibiotic susceptibility testing; Genetic: PPI selection based on the CYP2C19 gene polymorphism; Dietary Supplement: Probiotics usage based on the 16SrRNA sequencing

• Registration Number: NCT02689583
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

Since the discovery of Helicobacter pylori (H. pylori), many studies have been carried out with the goal of improving H. pylori eradication and therapies have changed from single-antibiotic treatments to the current multi-antibiotic treatments. However, the eradication rate of H. pylori is still less than 80%. The reasons for this low eradication rate are likely to be multi-factorial, including the reduced activity of antimicrobial drugs, poor patient compliance or micro-environment in stomach. In this study, to obtain the higher eradication of H. pylori and discover the different mechanism between the current infection and refractory infection of H. pylori, it is necessary to perform a prevalence survey for eradication of H. pylori based on the results from isolation of H. pylori strains, antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and 16SrRNA sequencing.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-02
• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-23
• Last Update Submitted: 2016-02-23
• Study First Posted: 2016-02-24
• Last Update Posted: 2016-02-24
• Study Start: 2016-03
• Primary Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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	PPI selection based on the CYP2C19 gene polymorphism	The patients with H. pylori infection have successful treatment based on the results from antibiotic susceptibility testing，CYP2C19 gene polymorphism，drug resistance gene sequencing and 16SrRNA sequencing.
refractory infection	Probiotics usage based on the 16SrRNA sequencing	The patients with H. pylori infection have failed treatment based on the results from antibiotic susceptibility testing，CYP2C19 gene polymorphism，drug resistance gene sequencing and 16SrRNA sequencing.
refractory infection	Antibiotic selection based on the antibiotic susceptibility testing	The patients with H. pylori infection have failed treatment based on the results from antibiotic susceptibility testing，CYP2C19 gene polymorphism，drug resistance gene sequencing and 16SrRNA sequencing.
Successful treatment	Antibiotic selection based on the antibiotic susceptibility testing	The patients with H. pylori infection have successful treatment based on the results from antibiotic susceptibility testing，CYP2C19 gene polymorphism，drug resistance gene sequencing and 16SrRNA sequencing.
Successful treatment	Probiotics usage based on the 16SrRNA sequencing	The patients with H. pylori infection have successful treatment based on the results from antibiotic susceptibility testing，CYP2C19 gene polymorphism，drug resistance gene sequencing and 16SrRNA sequencing.
refractory infection	PPI selection based on the CYP2C19 gene polymorphism	The patients with H. pylori infection have failed treatment based on the results from antibiotic susceptibility testing，CYP2C19 gene polymorphism，drug resistance gene sequencing and 16SrRNA sequencing.

Primary Outcome Measures

Name	Time	Method
Eradication rates	Three months	To investigate the eradication rates of H.Pylori after individual quadruple therapy based on antibiotic susceptibility testing, CYP2C19 gene polymorphism, drug resistance gene sequencing and 16SrRNA sequencing.
Mutation site of drug resistance gene	Three months	To discover the difference of mutation site in drug resistance gene between successful patients and refractory patients by second-generation sequencing.
The distribution and proportion of microflora in stomach	Three months	To discover the distribution and proportion of microflora in stomach between successful patients and refractory patients of H. Pylori infection by 16SrRNA sequencing.