CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 924 enrolled
Drug / intervention
23S rRNA point mutation test of Helicobacter pylori +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01453036
NCT01453036Phase 4Completed

Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance

Jin Il Kim·interventional·Posted Oct 17, 2011·Updated Sep 27, 2013

In Brief

A Phase 4 clinical trial evaluating 23S rRNA point mutation test of Helicobacter pylori and UBT test & Gastroenterology with biopsy c silver stain for Peptic Ulcer and Helicobacter Pylori Infection. Completed, enrolled 924 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2011
Enrollment StartAug 1, 2011
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.7 years ago

Interventions

23S rRNA point mutation test of Helicobacter pyloriprocedure

mutation test group\>\> Helicobacter pylori polymerase chain reaction kit by dual-priming oligonucleotide-based multiplex polymerase chain reaction system before eradication of Helicobacter pylori at mutation test groupConventional Conventional AOC group, Conventional AOM group \>\> no intervention

UBT test & Gastroenterology with biopsy c silver stainprocedure

UBT test \& Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group \>\> intervention