Clinical trial NCT02923856: A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Using Clarithromycin
Official title: A Multi-center Study for Eradication of Helicobacter Pylori With Triple Therapy Based on Accurate Susceptibility Testing of Clarithromycin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastritis
Keywords: Helicobacter pylori
Antibiotic resistance
Sequencing
Lead sponsor: Sanmen People's Hospital
Sponsor class: OTHER
Collaborators: name: Wenzhou Central Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Taizhou Hospital
name: Affiliated Wenling Hospital of Wenzhou Medical University
name: Hangzhou Medical College
name: Centers for Disease Control and Prevention, China
name: Zhiyuan Medical Inspection Institute
First posted: 2016-10-05
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As the resistant rate of the Helicobacter pylori to some common antibiotics was rising，the eradication rate of the Helicobacter pylori with the standard triple therapy failed to exceed 70% in China，and had to drop out of the first-line treatment recommendations. However, with the increase of treatment time, patients burden, adverse reactions of antibiotics or proton pump inhibitor (PPI) will also increase. Resistance to clarithromycin is the major cause of the failure to eradicate Helicobacter pylori. But, in terms of population, there are still more than 70% of the patients with clarithromycin sensitive. Under the guidance with susceptibility test，7-day standard triple therapy could be used. In this study, investigators will select the patients with infection of H. pylori and with clarithromycin sensitive. Eradication of Helicobacter pylori with triple therapy based on accurate susceptibility testing of clarithromycin will be studied. The treatment time will be assigned into 7 days,10 days and 14 days groups. Then, investigators will perform a sequencing for failed treatment patients in groups, such as drug resistance gene mutation, phenotype and genotype. Finally, investigators will compare the differences between the patients with triple therapy and traditional quadruple therapy.The incidence of adverse effects in the eradicate treatment will reduce at least 10% and avoid patients' unnecessary economic losses at least 400RMB per person.


Eligibility criteria: Inclusion Criteria:

1. Age 18\~70 years old, male or female, the first eradication therapy of H. pylori infection patients.
2. Symptoms of abdominal pain, bloating, acid efflux, 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. Within 3 months before with the drugs involved in other drugs research.
5. Esophageal,gastrointestinal surgery history.
6. Patients can not properly express their complaints,such as psychosis, severe neurosis.
7. Taking NSIAD or alcohol abusers.
8. Allergic to amoxicillin or clarithromycin tested by susceptibility testing.

Primary outcomes:
measure: The accurate determination of clarithromycin susceptibility.
timeFrame: 2 years
measure: Establish individualized precision triple therapy based on minimal inhibitory concentration.
timeFrame: 2.5 years
Secondary outcomes:
measure: The incidence of adverse effects
timeFrame: 3 years
Other outcomes:
measure: Impact of mixed infection and CYP2C19 genotype on eradication rate for Helicobacter pylori with triple therapy using clarithromycin.
timeFrame: 3 years
Locations:
city: Taizhou
country: China
facility: Sanmen People's hospital
state: Zhejiang
Study officials:
References: