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

NCT02689583 | Unknown

• 1 other identifier: FirstZhejiangU YMLi
• Study Type: interventional
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastritis; Gastric Ulcer

Keywords

Helicobacter pylori; Antibiotic resistance; Sequencing; Mechanism; Cause

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Successful treatment

EXPERIMENTAL

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; Genetic: PPI selection based on the CYP2C19 gene polymorphism; Dietary Supplement: Probiotics usage based on the 16SrRNA sequencing

refractory infection

EXPERIMENTAL

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; Genetic: PPI selection based on the CYP2C19 gene polymorphism; Dietary Supplement: Probiotics usage based on the 16SrRNA sequencing

Interventions

Antibiotic selection based on the antibiotic susceptibility testing BIOLOGICAL

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.

Successful treatment; refractory infection

PPI selection based on the CYP2C19 gene polymorphism GENETIC

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%.

Successful treatment; refractory infection

Probiotics usage based on the 16SrRNA sequencing DIETARY_SUPPLEMENT

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.

Successful treatment; refractory infection

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 4. 13C-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

• First Affiliated Hospital of Zhejiang University: lead
• Peking Union Medical College Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Third Affiliated Hospital of Third Military Medical University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Centers for Disease Control and Prevention, China: collaborator
• Academy Military Medical Science, China: collaborator

MeSH Terms

Conditions

Gastritis; Stomach Ulcer

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases

Study Officials

• Youming Li, professor

  First Affiliated Hospital of Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youming Li, professor

CONTACT

zlym@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Gastroenterology

Study Record Dates

• First Submitted: February 1, 2016
• First Posted: February 24, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2017
• Last Updated: February 24, 2016

Record last verified: 2016-02