Clinical trial NCT01453036: Clarithromycin Resistant Tailored Therapy
Official title: Eradication of Helicobacter Pylori According to 23S rRNA Point Mutations Associated With Clarithromycin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peptic Ulcer
Helicobacter Pylori Infection
Keywords: Peptic ulcer
Helicobacter pylori
Clarithromycin
23S rRNA
Resistance
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Korean College of Helicobacter and Upper Gastrointestinal Research
First posted: 2011-10-17
Enrollment: 924
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Helicobacter Pylori Eradication Rate
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gastroenterology Clinic
state: Yeouido-dong/Yeongdeungpo-gu
Study officials:
affiliation: Yeouido St. Mary's Hospital, The Catholic University of Korea
name: Hyun Jeong Lee, fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeouido St. Mary's Hospital, The Catholic University of Korea
name: Dae Young Cheung, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Seong Su Kim, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Byeong Ug Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Tae Ho Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Eun Jung Jeon
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Jung Hwan Oh, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Woo Chul Chung, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Soo Heon Park
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Jea Kwang Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Jin Il Kim
role: STUDY_CHAIR
References:
citation: Cho DK, Park SY, Kee WJ, Lee JH, Ki HS, Yoon KW, Cho SB, Lee WS, Joo YE, Kim HS, Choi SK, Rew JS. [The trend of eradication rate of Helicobacter pylori infection and clinical factors that affect the eradication of first-line therapy]. Korean J Gastroenterol. 2010 Jun;55(6):368-75. doi: 10.4166/kjg.2010.55.6.368. Korean.
citation: Bang SY, Han DS, Eun CS, Kim JE, Ahn SB, Sohn JH, Jeon YC, Kang JO. [Changing patterns of antibiotic resistance of Helicobacter pylori in patients with peptic ulcer disease]. Korean J Gastroenterol. 2007 Dec;50(6):356-62. Korean.