NCT01453036

Brief Summary

  1. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
924

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2011

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 27, 2013

Completed
Last Updated

September 27, 2013

Status Verified

July 1, 2013

Enrollment Period

10 months

First QC Date

September 29, 2011

Results QC Date

June 7, 2012

Last Update Submit

July 31, 2013

Conditions

Peptic UlcerHelicobacter Pylori Infection

Keywords

Peptic ulcerHelicobacter pyloriClarithromycin23S rRNAResistance

Outcome Measures

Primary Outcomes (1)

  • Helicobacter Pylori Eradication Rate

    Eradication was determined by the C13-urea breath test 6 to 8 weeks after the eradication therapy when PPIs had not been used for at least 2 weeks.

    8 weeks

Study Arms (3)

Conventional AOC group

ACTIVE COMPARATOR

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

Procedure: UBT test & Gastroenterology with biopsy c silver stain

Mutation test group

ACTIVE COMPARATOR

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

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

Conventional AOM group

ACTIVE COMPARATOR

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

Procedure: UBT test & Gastroenterology with biopsy c silver stain

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

Also known as: Seeplex ClaR-Helicobacter pylori polymerase chain reaction kit of Seegene Incorporated, Seoul, Korea
Mutation test group
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

Conventional AOC groupConventional AOM groupMutation test group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastroenterology Clinic

Seoul, Yeouido-dong/Yeongdeungpo-gu, 150-713, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 20571304RESULT

  • 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.

    PMID: 18159172RESULT

MeSH Terms

Conditions

Peptic Ulcer

Condition Hierarchy (Ancestors)

Duodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Results Point of Contact

Title
Dr. Jin Il Kim
Organization
The Catholic University of Korea
jikim@catholic.ac.kr
+82-2-3779-2382

Study Officials

  • Hyun Jeong Lee, fellow

    Yeouido St. Mary's Hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Dae Young Cheung, professor

    Yeouido St. Mary's Hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Seong Su Kim, professor

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Byeong Ug Kim

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Tae Ho Kim

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Eun Jung Jeon

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Jung Hwan Oh, Professor

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Woo Chul Chung, professor

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Soo Heon Park

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Jea Kwang Kim

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

  • Jin Il Kim

    The Catholic University of Korea

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 17, 2011

Study Start

August 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 27, 2013

Results First Posted

September 27, 2013

Record last verified: 2013-07

Locations

KR(1)