Helicobacter Pylori InfectionPhase 4NCT03556254
Genotypic Resistance Guided Versus Susceptibility Testing Guided Therapy for the First-line Eradication of H. Pylori
A Phase 4 study testing GGT and SGT in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- GGT and SGT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Mar 2018to 30 Jun 2022
- 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
- Adult patients aged greater than 20 years with H. pylori infection naïve to treatment are considered eligible for enrollment..
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, Yun-Lin Branch
Yun-Lin County
Chieh-Chang Chen, MD
Chieh-Chang Chan, MD
About this study
Official title: Comparison of Genotypic Resistance Guided Versus Susceptibility Testing Guided Therapy for the First-line Eradication of H. Pylori- a Multicenter Randomized Trial
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
Read the detailed description
Background: Recent trials have shown that susceptibility testing guided therapy was more effective than empirical triple therapy given for 7-10 days in the first-line treatment of H. pylori infection. However, susceptibility testing is time consuming and inconvenient, limiting the widespread application of susceptibility testing guided therapy in clinical practice. Recently, point mutations at 23S rRNA and gyrase A have reported to be associated with clarithromycin and levofloxacin resistance. However, whether genotypic resistance guided therapy is more effective or non-inferior to susceptibility guided therapy has not been reported. Besides, the long term impact of H. pylori eradication on the gut microbiota and metabolic disorders remains unclear. Aim: Therefore, 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 factorsMethods: This will be a multi-center, open labeled trialPatients: 560 patients with H. pylori infection naïve to eradication therapy will be enrolled Testing for H. pylori infectionBefore First Line TreatmentAny two positive of CLO test, histology, HpSA, and culture will be considered as H. pylori infectedAfter First-Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8 weeks after first line therapy. Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year after eradication therapy Determination of antibiotic resistance of H. pylori: E-test will be used to determine the minimum inhibitory concentrations of clarithromycin and levofloxacin to guide the selection of antibiotics. Agar dilution test will also be done. Mutations in 23S rRNA and gyrase A will also be determined by PCR followed by direct sequencing Treatment regimens and assignment Eligible patients will be randomized to receive either one of the treatments (A) Genotypic resistance guided therapy: 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. (B) Susceptibility testing guided therapy: 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. The stool samples will be collected before, and 2 and 8 weeks and 1 year after eradication therapy to analyze the changes in the antibiotic resistance and microbiota of gut floraThe body weight, waist and hip circumference and serum lipid profile, sugar, and HbA1C levels will be collected before and 8 weeks and 1 year after eradication therapy.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- GGT, SGT
- Keywords
- Helicobacter pylori infection, Genotypic resistance, Antimicrobial susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GGT |
| Susceptibility testing guided therapy | Active comparator | Tailored therapy according to the minimum inhibitory concentration result (susceptibility testing, E-test) Receives: Drug: SGT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (1)
adverse effects during eradication therapies
a standard interview will be arranged at the end of treatment to assess the adverse effects
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start29 Mar 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jyh-Ming Liou, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556254
- Sponsor's protocol ID
- 201706038MINC
- Status last verified
- Jan 2018
- First submitted
- 4 Jun 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37178702
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Genotypic Resistance Guided Versus Susceptibility Testing Guided Therapy for the First-line Eradication of H. Pylori- a Multicenter Randomized Trial
- ClinicalTrials.gov ID
- NCT03556254
- Acronym / sponsor ID
- 201706038MINC
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori infection, Genotypic resistance, Antimicrobial susceptibility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Mar 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Background: Recent trials have shown that susceptibility testing guided therapy was more effective than empirical triple therapy given for 7-10 days in the first-line treatment of H. pylori infection. However, susceptibility testing is time consuming and inconvenient, limiting the widespread application of susceptibility testing guided therapy in clinical practice. Recently, point mutations at 23S rRNA and gyrase A have reported to be associated with clarithromycin and levofloxacin resistance. However, whether genotypic resistance guided therapy is more effective or non-inferior to susceptibility guided therapy has not been reported. Besides, the long term impact of H. pylori eradication on the gut microbiota and metabolic disorders remains unclear. Aim: Therefore, 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 factorsMethods: This will be a multi-center, open labeled trialPatients: 560 patients with H. pylori infection naïve to eradication therapy will be enrolled Testing for H. pylori infectionBefore First Line TreatmentAny two positive of CLO test, histology, HpSA, and culture will be considered as H. pylori infectedAfter First-Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8 weeks after first line therapy. Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year after eradication therapy Determination of antibiotic resistance of H. pylori: E-test will be used to determine the minimum inhibitory concentrations of clarithromycin and levofloxacin to guide the selection of antibiotics. Agar dilution test will also be done. Mutations in 23S rRNA and gyrase A will also be determined by PCR followed by direct sequencing Treatment regimens and assignment Eligible patients will be randomized to receive either one of the treatments (A) Genotypic resistance guided therapy: 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. (B) Susceptibility testing guided therapy: 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. The stool samples will be collected before, and 2 and 8 weeks and 1 year after eradication therapy to analyze the changes in the antibiotic resistance and microbiota of gut floraThe body weight, waist and hip circumference and serum lipid profile, sugar, and HbA1C levels will be collected before and 8 weeks and 1 year after eradication therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotypic resistance guided therapy | Experimental | Drug: GGTIn 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. |
| Susceptibility testing guided therapy | Active comparator | Drug: SGTTailored therapy according to the minimum inhibitory concentration result (susceptibility testing, E-test) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged greater than 20 years with H. pylori infection naïve to treatment are considered eligible for enrollment..
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GGTIn 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 | Genotypic resistance guided therapy |
| SGTIn 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. | Drug | Susceptibility testing guided therapy |
Primary outcome
Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses
Time frame: 6 weeks
Urea breath testing will be done at least 6 weeks after completion of eradication therapy
1 secondary outcome
adverse effects during eradication therapies
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Derived from this study: PubMed 37178702Chen 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.
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
Not yet recruitingPhase 2
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
Helicobacter Pylori Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jyh-Ming Liou principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GGT and SGT in people with Helicobacter Pylori Infection, run by National Taiwan 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 30 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jyh-Ming Liou (23123456 ext. 63541, jyhmingliou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate will be evaluated according to Intent-to-treat (ITT) analyses (time frame: 6 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 NCT03556254, which also lists 1 linked publication.
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 30 Oct 2018.