Optimal Tailored Treatment for H. Pylori Infection

NCT04462133 | Withdrawn

• 1 other identifier: XC20ENDT0022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection; Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (1)

• Eradication success

  H. pylori eradication success based on urea breath test

  8-12 weeks after eradication

Study Arms (2)

Empirical therapy for H. pylori infection

ACTIVE COMPARATOR

The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication

Diagnostic Test: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)

Tailored therapy for H. pylori infection

EXPERIMENTAL

The tailored therapy group receives eradication regimens based on their DPO-PCR results. Triple therapy of 7 or 14 days for clarithromycin sensitive patients based on DPO-PCR and bismuth quadruple therapy of 7 or 14 days for clarithromycin resistant patients based on DPO-PCR.

Diagnostic Test: Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)

Interventions

Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) DIAGNOSTIC_TEST

Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results

Empirical therapy for H. pylori infection; Tailored therapy for H. pylori infection

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Incheon St.Mary's Hospital: lead

Study Sites (1)

Incheon St. Mary's Hospital

Incheon, South Korea

Location

Study Officials

• Byung-Wook Kim, MD, PhD

  Incheon St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Model Details: Empirical treatment versus tailored therapy

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 8, 2020
• Study Start: September 1, 2020
• Primary Completion: March 31, 2024
• Study Completion: October 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)