AzTrials
AzTrials

Helicobacter PyloriPhase 4BSUS-2NCT06687499

14-day Susceptibility-guided Bismuth Quadruple Therapy for Multiple Drug Resistant H. Pylori Infection

A Phase 4 study testing Bismuth-based susceptibility-guided treatment in people with Helicobacter Pylori and Drug Resistance, Multiple, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn if the 14-day susceptibility-guided bismuth quadruple therapy works to treat multiple drug resistant Helicobacter pylori (H. pylori) in adults. It will also learn about the adverse effects of bismuth quadruple therapy. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Bismuth-based susceptibility-guided treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteTaiwan
Study dates
22 Aug 2022to 26 Jan 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • H. pylori-infected with treatment experience with at least one course of eradication failure
  • H. pylori-infected with treatment naïve but having multiple-drug resistant H. pylori (>= three antibiotics)
  • H. pylori infection confirmed by H. pylori culture

Who cannot join

  • Previous allergic reactions to regimens, including amoxicillin, bismuth subcitrate, esomeprazole, metronidazole, rifabutin, and tetracycline,
  • Severe comorbidities,
  • Chronic kidney disease with estimated glomerular filtration rate < 60 ml/min/1.73 m2,
  • Pregnant or breastfeeding women.
  • Dual-resistant H. pylori infection
  • Mono-resistant H. pylori infection
Show all 10Show fewer
  • All susceptible H. pylori infection
  • Positive RUT but negative H. pylori culture
  • Negative RUT and negative H. pylori culture
  • Decline to participate

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • National Cheng Kung University Hospital

    Tainan, Taiwan, 704302

Other trials in Taiwan

About this study

Official title: The Study of Adding Bismuth on Susceptibility-based Regimen Strategy to Enhance the Eradication Rate for Multi-resistant H. Pylori Infection

The goal of this clinical trial is to learn if the 14-day susceptibility-guided bismuth quadruple therapy works to treat multiple drug resistant Helicobacter pylori (H. pylori) in adults. It will also learn about the adverse effects of bismuth quadruple therapy. The main questions it aims to answer are:

  • Does 14-day susceptibility-guided bismuth quadruple therapy higher the eradication rate?
  • What medical problems do participants have when taking 14-day susceptibility-guided bismuth quadruple? Researchers will record 14-day susceptibility-guided bismuth quadruple to see if 14-day susceptibility-guided bismuth quadruple works to treat multiple drug resistant H. pylori.
Read more

Participants will:

  • Take susceptibility-guided bismuth quadruple every day for 14 days
  • Visit the clinic once 4-6 weeks for checkups and tests
  • Keep a diary of their symptoms during taking susceptibility-guided bismuth quadruple
Read the detailed description

Helicobacter pylori (H. pylori) infection is the major culprit of dyspeptic symptoms, peptic ulcer disease, gastric adenocarcinoma, and gastric mucosa-associated lymphoid tissue lymphoma.

The antibiotic resistance of H. pylori infection is an emerging issue. Moreover, amoxicillin-resistant H. pylori strains increased recently. The amoxicillin resistance rates were 9% in Asia and up to 39% in South America.

Susceptibility-guided therapy is superior to empiric therapy in 2nd-line therapy. After twice eradication failure, H. pylori culture for susceptibility test is strongly recommended, which guide clinician to choose appropriate susceptibility-based therapy. The multiple drug resistant rates may be higher in patients who fail two or more eradication therapy; thus, susceptibility-guided therapy is currently the consensus recommendation for 3rd-line H. pylori eradication. Bismuth quadruple therapy could overcome either clarithromycin or metronidazole resistant strains. Several evidences of clinical randomized-controlled trials demonstrated that adding bismuth as the first line therapeutic regimen can capture additional 30%-40% successful eradication rate for the resistant strain, further contributing to the overall eradication rate.

Accordingly, the aim of our study was to validate the susceptibility-guided bismuth quadruple therapy in patients with multiple drug resistant H. pylori infection in terms of efficacy and side effects.

Being tested
Bismuth-based susceptibility-guided treatment
Keywords
bismuth, microbial sensitivity tests, Helicobacter pylori, drug resistance, multiple

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bismuth-based susceptibility-guided treatmentDrug

    The investigators design four regimes for H. pylori eradication and participants receive one of the regimens based on susceptibility test. The four regimens are PBAT for those with both amoxicillin and tetracycline susceptible H. pylori; PBAM for those with amoxicillin susceptible but tetracycline resistant H. pylori; PBMT for those with amoxicillin resistant but tetracycline susceptible H. pylori; PBMR for those with both amoxicillin and tetracycline resistant H. pylori. A is amoxicillin (1000 mg thrice daily), B is colloidal bismuth subcitrate (120 mg thrice daily), M is metronidazole (500 mg thrice daily), P is a proton pump inhibitor, i.e., esomeprazole (40 mg twice daily), R is rifabutin (150 mg twice daily), and T is tetracycline (500 mg thrice daily). The treatment duration is 14 days for all regimens.

Study groups in NCT06687499
Study groupRoleWhat they receive
Bismuth-based susceptibility-guided treatmentExperimentalParticipants who have triple- or quadruple-drug resistant H. pylori infection are enrolled. Participants receive one of the four regimens based on susceptibility test.
Receives: Drug: Bismuth-based susceptibility-guided treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The eradication rate of H. pylori

    The investigators define successful eradication as a negative 13C-urea breath test or a negative H. pylori stool antigen test at 4 to 6 weeks after the completion of H. pylori eradication and discontinuation of antibiotics and proton pump inhibitors. The eradication rates are determined by intention-to-treat and per-protocol analyses. The intention-to-treat analysis evaluates all enrolled participants. The per-protocol analysis evaluates those who take >= 80% of the study medications and receive post-treatment 13C-urea breath test or an H. pylori stool antigen test. The successful rate is represented with a percentage (%).

    Measured: From enrollment to the end of treatment at 6-8 weeks

Secondary outcomes (2)

  1. Adverse effects

    Adverse events are assessed by a physician and a format questionnaire survey after the end of treatment. Serious adverse events are defined as daily activities restricted or participant unable to work. The adverse events include dizziness, skin rash, headache, unpleasant taste/bitter, abdominal pain, nausea, vomiting, diarrhea, constipation, abdominal fullness, glossitis/sore throat, darkened stool, fatigue, anorexia, chest burn, palpitation, and vaginal discharge. All adverse events are classified as none, mild (not restricting daily activities), or serious (restricting daily activities or causing inability to work).

    Measured: From enrollment to the end of treatment at 2 weeks

  2. Adherence to medications

    Adherence to medications is evaluated by questionnaire surveys after treatment completion. Adherence of medications is categorized as good (≥ 80% medication taken) or poor (< 80% medication taken).

    Measured: From enrollment to the end of treatment at 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start22 Aug 2022
  3. Primary completion31 Dec 2023
  4. Study completion26 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06687499
Sponsor's protocol ID
B-BR-111-042
Acronym
BSUS-2
Status last verified
Oct 2024
First submitted
5 Nov 2024
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fischbach L, Evans EL. Meta-analysis: the effect of antibiotic resistance status on the efficacy of triple and quadruple first-line therapies for Helicobacter pylori. Aliment Pharmacol Ther. 2007 Aug 1;26(3):343-57. doi: 10.1111/j.1365-2036.2007.03386.x.

    PubMed 17635369

  • Marzio L, Coraggio D, Capodicasa S, Grossi L, Cappello G. Role of the preliminary susceptibility testing for initial and after failed therapy of Helicobacter pylori infection with levofloxacin, amoxicillin, and esomeprazole. Helicobacter. 2006 Aug;11(4):237-42. doi: 10.1111/j.1523-5378.2006.00407.x.

    PubMed 16882326

  • Thung I, Aramin H, Vavinskaya V, Gupta S, Park JY, Crowe SE, Valasek MA. Review article: the global emergence of Helicobacter pylori antibiotic resistance. Aliment Pharmacol Ther. 2016 Feb;43(4):514-33. doi: 10.1111/apt.13497. Epub 2015 Dec 23.

    PubMed 26694080

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bismuth-based susceptibility-guided treatment in people with Helicobacter Pylori and Drug Resistance, Multiple, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The eradication rate of H. pylori (time frame: From enrollment to the end of treatment at 6-8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06687499, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in