ClinicalTrials.Veeva

Menu

Clarithromycin Resistant Tailored Therapy

J

Jin Il Kim

Status and phase

Completed
Phase 4

Conditions

Peptic Ulcer
Helicobacter Pylori Infection

Treatments

Procedure: UBT test & Gastroenterology with biopsy c silver stain
Procedure: 23S rRNA point mutation test of Helicobacter pylori

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

  1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance
  2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate Helicoabacter pylori more successfully
  3. Material & methods The investigators enroll patients diagnosed with peptic ulcer, endoscopically. Helicobacter pylori is documented with Urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.

Enrollment

924 patients

Sex

All

Ages

20 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 20 - 75 years old
  • Peptic ulcer (gastric ulcer, duodenal ulcer)
  • Helicobacter pylori positive

Exclusion criteria

  • Major comorbidities
  • Pregnancy
  • History of Helicobacter pylori eradication
  • History of gastric surgery or other cancers, except to endoscopic treatment due to gastric lesion

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

924 participants in 3 patient groups

Conventional AOC group
Active Comparator group
Description:
The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
Treatment:
Procedure: UBT test & Gastroenterology with biopsy c silver stain
Mutation test group
Active Comparator group
Description:
Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
Treatment:
Procedure: UBT test & Gastroenterology with biopsy c silver stain
Procedure: 23S rRNA point mutation test of Helicobacter pylori
Conventional AOM group
Active Comparator group
Description:
The investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
Treatment:
Procedure: UBT test & Gastroenterology with biopsy c silver stain

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems