NCT03556254

Brief Summary

We aimed to (1) compare the efficacy of genotypic resistance guided sequential therapy vs. susceptibility testing guided therapy in the first-line therapy (2) assess the long term impact of eradication therapy on the antibiotic resistance and microbiota of the gut flora and the metabolic factors in this multi-center, open labeled trial

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
560

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2018

Longer than P75 for phase_4

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

March 29, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

October 30, 2018

Status Verified

January 1, 2018

Enrollment Period

3.3 years

First QC Date

June 4, 2018

Last Update Submit

October 28, 2018

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori infectionGenotypic resistanceAntimicrobial susceptibility

Outcome Measures

Primary Outcomes (1)

  • Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses

    Urea breath testing will be done at least 6 weeks after completion of eradication therapy

    6 weeks

Secondary Outcomes (1)

  • adverse effects during eradication therapies

    2 weeks

Study Arms (2)

Genotypic resistance guided therapy

EXPERIMENTAL

In the absence of 23S rRNA mutation, clarithromycin based sequential therapy will be given. In the presence of 23S rRAN mutation but the absence of gyrase A mutation, levofloxacin based sequential therapy will be given. In the presence of both 23S rRNA and gyrase A mutations or if genotyping fails, bismuth quadruple therapy will be given.

Drug: GGT

Susceptibility testing guided therapy

ACTIVE COMPARATOR

Tailored therapy according to the minimum inhibitory concentration result (susceptibility testing, E-test)

Drug: SGT

Interventions

GGTDRUG

In the absence of 23S rRNA mutation, clarithromycin based sequential therapy will be given. In the presence of 23S rRAN mutation but the absence of gyrase A mutation, levofloxacin based sequential therapy will be given. In the presence of both 23S rRNA and gyrase A mutations or if genotyping fails, bismuth quadruple therapy will be given

Genotypic resistance guided therapy
SGTDRUG

In the absence of clarithromycin resistance, clarithromycin based sequential therapy will be given. In the presence of clarithromycin resistance but the absence of levofloxacin resistance, levofloxacin based sequential therapy will be given. In the presence of both clarithromycin and levofloxacin resistance or if culture fails, bismuth quadruple therapy will be given.

Susceptibility testing guided therapy

Eligibility Criteria

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

You may qualify if:

  • Adult patients aged greater than 20 years with H. pylori infection naïve to treatment are considered eligible for enrollment..

You may not qualify if:

  • children and teenagers aged less than 20 years
  • history of gastrectomy
  • gastric malignancy, including adenocarcinoma and lymphoma
  • previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole, bismuth) and prompt pump inhibitors (esomeprazole)
  • contraindication to treatment drugs
  • pregnant or lactating women
  • severe concurrent disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, Yun-Lin Branch

Yun-Lin County, Taiwan

RECRUITING

Related Publications (1)

  • Chen MJ, Chen PY, Fang YJ, Bair MJ, Chen CC, Chen CC, Yang TH, Lee JY, Yu CC, Kuo CC, Chiu MC, Chou CK, Chen CY, Hu WH, Tsai MH, Hsu YC, Shun CT, Luo JC, Lin JT, El-Omar EM, Wu MS, Liou JM; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Molecular testing-guided therapy versus susceptibility testing-guided therapy in first-line and third-line Helicobacter pylori eradication: two multicentre, open-label, randomised controlled, non-inferiority trials. Lancet Gastroenterol Hepatol. 2023 Jul;8(7):623-634. doi: 10.1016/S2468-1253(23)00097-3. Epub 2023 May 10.

    PMID: 37178702DERIVED

Study Officials

  • Jyh-Ming Liou

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jyh-Ming Liou

CONTACT

23123456jyhmingliou@gmail.com

Study Design

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

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 14, 2018

Study Start

March 29, 2018

Primary Completion

June 30, 2021

Study Completion

June 30, 2022

Last Updated

October 30, 2018

Record last verified: 2018-01

Locations

TW(1)