NCT04006340

Brief Summary

We aimed to compare the efficacy of genotypic resistance-guided tailored therapy vs empirical therapy for eradication of Helicobacter pylori (H. pylori) infection in randomized controlled trials.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 4, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

8 months

First QC Date

June 28, 2019

Last Update Submit

July 1, 2019

Conditions

Helicobacter Pylori 23S rRNA Clarithromycin Resistance MutationHelicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • Eradication rate

    Eradication rate of H. pylori infection

    13C-UBT at least 4 weeks after completion of treatment

Study Arms (2)

Empirical group

PLACEBO COMPARATOR

Patients receive conventional triple therapy containing esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days

Combination Product: triple therapy

Genotypic resistance-guided tailored group

ACTIVE COMPARATOR

Patients receive triple or quadruple therapy by resistance-associated mutations in 23S ribosomal RNA which are identified by polymerase chain reaction (PCR). Triple therapy contains esomeprazole 40 mg, amoxicillin 1 g and clarithromycin 500 mg twice a day for 10 days and quadruple therapy contains esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days.

Combination Product: triple therapyCombination Product: quadruple therapyDiagnostic Test: dual-priming oligonucleotide-based multiplex (DPO)-PCR test

Interventions

triple therapyCOMBINATION_PRODUCT

esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days

Empirical groupGenotypic resistance-guided tailored group
quadruple therapyCOMBINATION_PRODUCT

esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days

Genotypic resistance-guided tailored group
dual-priming oligonucleotide-based multiplex (DPO)-PCR testDIAGNOSTIC_TEST

Resistance of clarithromycin 23S rRNA point mutation

Genotypic resistance-guided tailored group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with H. pylori who had undergone endoscopic resection for gastric neoplasm
  • Patients with H. pylori who had diagnosed at peptic ulcer disease, MALT lymphoma

You may not qualify if:

  • history of gastrectomy
  • patients aged younger than 20 years or older than 80 years
  • history of H. pylori eradication therapies or other antibiotics therapy within a month
  • previous allergic reaction to the study drugs (amoxicillin, clarithromycin, metronidazole, tetracycline, and esomeprazole)
  • contraindication to treatment drugs
  • pregnant or lactating women
  • severe concurrent illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

  • Kim JL, Cho SJ, Chung SJ, Lee A, Choi J, Chung H, Kim SG. Empiric Versus Clarithromycin Resistance-Guided Therapy for Helicobacter pylori Based on Polymerase Chain Reaction Results in Patients With Gastric Neoplasms or Gastric Mucosa-Associated Lymphoid Tissue Lymphoma: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2020 Sep;11(9):e00194. doi: 10.14309/ctg.0000000000000194.

    PMID: 33094958DERIVED

Study Officials

  • Soo-Jeong Cho, M.D., ph.D.

    Department of Internal Medicine and Liver Research Institute,

    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
Clinical Associate Professor

Study Record Dates

First Submitted

June 28, 2019

First Posted

July 5, 2019

Study Start

January 4, 2019

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

KR(1)