Tailored H. Pylori Eradication Based on Clarithromycin Resistance

Helicobacter Pylori Infection Clinical Trial

Official title:

Helicobacter Pylori Eradication According to Sequencing-based 23S Ribosomal RNA Point Mutation Associated With Clarithromycin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03884348
• Other study ID #: Kangdong2017-03-005
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Kangdong Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators investigated the point mutations in the 23S rRNA genes of patients infected with clarithromycin-resistant H. pylori and compared the H. pylori eradication rates based on the identified clinically significant point mutations.

Description:

Sequencing-based detection of point mutations identified four mutations that were considered clinically significant (A2142G, A2142C, A2143G, A2143C), while all the other mutations were considered clinically insignificant.

Participants who did not have point mutations related to clarithromycin resistance and/or had clinically insignificant point mutations were treated with PAC (proton pump inhibitor, amoxicillin, clarithromycin) for 7 days, while participants with clinically significant point mutations were treated with PAM (proton pump inhibitor, amoxicillin, metronidazole) for 7 days. H. pylori eradication rates were compared between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 431
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Helicobacter pylori infection

Exclusion Criteria:

• H. pylori eradication therapy within 1 year,

• antibiotics within 4 weeks,

• surgery for gastric cancer

• malignant tumors other than gastric cancer

• end-stage renal disease

• liver cirrhosis,

• pregnancy

Related Conditions & MeSH terms

• Antibiotic Resistant Strain
• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• proton pump inhibitor, amoxicillin, clarithromycin
non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin
• proton pump inhibitor, amoxicillin, metronidazole
clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kangdong Sacred Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication rate	Number of participant with successful Helicobacter pylori eradication	2 year