Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02689583
Recruitment Status : Unknown
Verified February 2016 by Youming Li, First Affiliated Hospital of Zhejiang University.
Recruitment status was:  Not yet recruiting
First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Collaborators:
Peking Union Medical College Hospital
Nanfang Hospital of Southern Medical University
Third Affiliated Hospital of Third Military Medical University
The First Affiliated Hospital with Nanjing Medical University
Centers for Disease Control and Prevention, China
Academy Military Medical Science, China
Information provided by (Responsible Party):
Youming Li, 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.

Condition or disease Intervention/treatment Phase
Gastritis Gastric Ulcer 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 Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Multi-center Study for Individual Treatment of Helicobacter Pylori Infection
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Successful treatment
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.
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.

Experimental: refractory infection
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.
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.




Primary Outcome Measures :
  1. Eradication rates [ Time Frame: 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.

  2. Mutation site of drug resistance gene [ Time Frame: Three months ]
    To discover the difference of mutation site in drug resistance gene between successful patients and refractory patients by second-generation sequencing.

  3. The distribution and proportion of microflora in stomach [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02689583


Contacts
Layout table for location contacts
Contact: Youming Li, professor zlym@zju.edu.cn

Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Peking Union Medical College Hospital
Nanfang Hospital of Southern Medical University
Third Affiliated Hospital of Third Military Medical University
The First Affiliated Hospital with Nanjing Medical University
Centers for Disease Control and Prevention, China
Academy Military Medical Science, China
Investigators
Layout table for investigator information
Principal Investigator: Youming Li, professor First Affiliated Hospital of Zhejiang University

Layout table for additonal information
Responsible Party: Youming Li, Director of the Department of Gastroenterology, First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier: NCT02689583     History of Changes
Other Study ID Numbers: FirstZhejiangU YMLi
First Posted: February 24, 2016    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016

Keywords provided by Youming Li, First Affiliated Hospital of Zhejiang University:
Helicobacter pylori
Antibiotic resistance
Sequencing
Mechanism
Cause

Additional relevant MeSH terms:
Layout table for MeSH terms
Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Helicobacter Infections
Gastritis
Stomach Ulcer
Gram-Negative Bacterial Infections
Bacterial Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Antibiotics, Antitubercular