Optimal Tailored Treatment for H. Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

Optimal Tailored Treatment for H. Pylori Infection According to the Presence of DPO-PCR Based Clarithromycin Resistance

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04462133
• Other study ID #: XC20ENDT0022
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: October 1, 2024

Study information

• Verified date: July 2020
• Source: Incheon St.Mary's Hospital
• Contact: Byung-Wook Kim, MD, PhD
• Phone: 82-32-280-5057
• Email: gastro[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a dual‐priming oligonucleotide (DPO)‐based multiplex polymerase chain reaction (PCR) assay was introduced and made commercially available. The primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. Specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.

Description:

Patients are randomly assigned to the empirical therapy group and tailored therapy group.

The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy group receives treatment based on their DPO-PCR results.

Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7 or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth quadruple therapy for 7 or 14 days.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1988
• Est. completion date: October 1, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

Inclusion Criteria:

• consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of H pylori infection

Exclusion Criteria:

• subjects younger than 18 years old

• subjects with a history of H pylori eradication

• subjects who had previous gastric surgery

• subjects who were pregnant or lactating

• subjects with serious concurrent illness

• subjects who were administered antibiotics, bismuth, or PPIs in the 8 weeks preceding the study

• subjects with a history of allergy to any one of the compounds in this study

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Communicable Diseases
• Helicobacter Pylori Infection
• Infection

Intervention

Diagnostic Test:
• Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)
Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Incheon St.Mary's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication success	H. pylori eradication success based on urea breath test	8-12 weeks after eradication