NCT03156855

Brief Summary

The investigators aimed to

  1. 1.compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the first line and second line treatment
  2. 2.assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
  3. 3.assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
  4. 4.assess the impact of eradication therapy on the metabolic factors

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
620

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2015

Longer than P75 for phase_4

Geographic Reach
1 country

7 active sites

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

September 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 17, 2017

Status Verified

May 1, 2017

Enrollment Period

3.3 years

First QC Date

September 30, 2015

Last Update Submit

May 16, 2017

Conditions

Helicobacter

Keywords

efficacysafetyH. pylori eradication

Outcome Measures

Primary Outcomes (1)

  • Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis)

    No eradicated divided by total cases by intention to treat analysis. 13C-UBT will be used to determine the H. pylori status at least 6 weeks after completion of treatment. A delta value of \> 4 units will be defined as positive for H. pylori infection as our previous studies.

    6 weeks

Secondary Outcomes (2)

  • adverse effect: occurrence of any adverse effect during the treatment

    2 weeks

  • changes of antibiotic resistance

    2 weeks, 8 weeks, 1 year

Other Outcomes (1)

  • changes of gut microbiota

    2 weeks, 8 weeks, 1 year

Study Arms (2)

sequential therapy for 14 days (S14)

EXPERIMENTAL

14 day sequential therapy

Drug: 14-day sequential therapy

bismuth quadruple therapy (Q10)

ACTIVE COMPARATOR

Bismuth quadruple therapy

Drug: Bismuth quadruple therapy

Interventions

14-day sequential therapyDRUG

D1-D7: (esomeprazole 40mg qid + amoxicillin 500mg qid) for 7 days D8-D14: (esomeprazole 40mg qid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days

Also known as: S14
sequential therapy for 14 days (S14)
Bismuth quadruple therapyDRUG

D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days

Also known as: Q10
bismuth quadruple therapy (Q10)

Eligibility Criteria

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

You may qualify if:

  • \. H. pylori infected patients naïve to eradication therapies will be eligible in this study.

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 (bismuth, amoxicillin, metronidazole, clarithromycin, tetracycline) and PPI (esomeprazole),
  • contraindication to treatment drugs,
  • pregnant or lactating women,
  • severe concurrent disease,
  • concomitant use of clopidogrel, or (9) Unwilling to accept random assignment of subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chiayi Christian Hospital

Chiayi City, Taiwan

RECRUITING

National Taiwan University Hospital, Hsinchu Branch

Hsinchu, Taiwan

RECRUITING

E-DA University Hospital

Kaohsiung City, Taiwan

RECRUITING

Jyh-Ming Liou

Taipei, Taiwan

RECRUITING

Taipei Veteran General Hospital

Taipei, Taiwan

RECRUITING

Mackay Memorial Hospital, Taitung branch

Taitung, Taiwan

RECRUITING

National Taiwan University Hospital, Yun-Lin Branch

Yunlin County, Taiwan

RECRUITING

Related Publications (1)

  • Liou JM, Chen CC, Fang YJ, Chen PY, Chang CY, Chou CK, Chen MJ, Tseng CH, Lee JY, Yang TH, Chiu MC, Yu JJ, Kuo CC, Luo JC, Hsu WF, Hu WH, Tsai MH, Lin JT, Shun CT, Twu G, Lee YC, Bair MJ, Wu MS; Members of the Taiwan Gastrointestinal Disease and Helicobacter Consortium. 14 day sequential therapy versus 10 day bismuth quadruple therapy containing high-dose esomeprazole in the first-line and second-line treatment of Helicobacter pylori: a multicentre, non-inferiority, randomized trial. J Antimicrob Chemother. 2018 Sep 1;73(9):2510-2518. doi: 10.1093/jac/dky183.

    PMID: 29846605DERIVED

MeSH Terms

Interventions

ribosomal protein S14Tuberculin

Intervention Hierarchy (Ancestors)

Antigens, BacterialBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Ming-Shiang Wu, MD, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR

Central Study Contacts

Jyh-Ming Liou, MD, PhD

CONTACT

dtmed046@pchome.com.tw

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

September 30, 2015

First Posted

May 17, 2017

Study Start

September 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

May 17, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(7)