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

Gastritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02689583
• Other study ID #: FirstZhejiangU YMLi
• Status: Not yet recruiting
• Phase: N/A
• First received: February 1, 2016
• Last updated: February 23, 2016
• Start date: March 2016

Study information

• Verified date: February 2016
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Youming Li, professor
• Email: zlym[@]zju.edu.cn
• Is FDA regulated: No
• Health authority: China: Centers for Disease Control and Prevention
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3000
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Ulcer
• Gastritis
• Helicobacter Infections
• Stomach Ulcer

Intervention

Biological:
• Antibiotic selection based on the antibiotic susceptibility testing
The biological intervention focused on the results from the antibiotic susceptibility testing. All patients should used the their susceptibility antibiotics according to antibiotic susceptibility testing of H. pylori. Considering the safety of drug usage, priority antibiotic selection was as follow: Amoxicillin > Clarithromycin > Levofloxacin >Tetracycline > Furazolidone > Metronidazole.

Genetic:
• PPI selection based on the CYP2C19 gene polymorphism
PPI selection should based on the CYP2C19 gene polymorphism of patients. Patients have different metabolizers, such as poor metabolizers (PM), extensive metabolizers (EM) and intermediate metabolizer (IM). Different metabolism of patients should select different PPI or different doses of PPI. For IM and PM, in this study, patients selected the standard dose of Omeprazole. For EM, in this study, patients selected the Esomeprazole with increasing doses 50%-100%.

Dietary Supplement:
• Probiotics usage based on the 16SrRNA sequencing
Different micro-environment in stomach may influence the antibiotic absorption. In this study, some patients could select probiotic as adjuvant therapy according to their micro-environment in stomach by 16SrRNA sequencing.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	Academy Military Medical Science, China, Centers for Disease Control and Prevention, China, Nanfang Hospital of Southern Medical University, Peking Union Medical College Hospital, The First Affiliated Hospital with Nanjing Medical University, Third Affiliated Hospital of Third Military Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rates	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.	Three months	Yes
Primary	Mutation site of drug resistance gene	To discover the difference of mutation site in drug resistance gene between successful patients and refractory patients by second-generation sequencing.	Three months	Yes
Primary	The distribution and proportion of microflora in stomach	To discover the distribution and proportion of microflora in stomach between successful patients and refractory patients of H. Pylori infection by 16SrRNA sequencing.	Three months	Yes