Effectiveness of tailored and conventional therapy in H. pylori treatment of Vietnamese patients
| ISRCTN | ISRCTN58374617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58374617 |
| Secondary identifying numbers | 256/QĐ-SKHCN |
- Submission date
- 01/03/2022
- Registration date
- 02/03/2022
- Last edited
- 02/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Infection with Helicobacter pylori (H. pylori) bacteria can lead to a peptic ulcer (a sore on the lining of the stomach, small intestine or food pipe). Tailored therapy has been reported to achieve a higher eradication rate than conventional therapy in treating patients infected with H. pylori who have not been treated before. However, there is little information about its effectiveness in patients who previously failed treatment. The aim of this study is to evaluate the H. pylori eradication effectiveness of bismuth quadruple therapy and tailored therapy based on antibiotic susceptibility and the CYP2C19 genotype of Vietnamese patients after treatment failure.
Who can participate?
Patients aged over 18 years old with peptic ulcers who have a record of H. pylori treatment failure and a confirmed infection
What does the study involve?
Participants are randomly allocated into two groups: conventional therapy and tailored therapy. The tailored group are tested for their CYP2C19 genotype and susceptibility for five antibiotics (amoxicillin, clarithromycin, levofloxacin, tetracycline and metronidazole). The conventional group receive a bismuth quadruple therapy while the tailored group are treated with adjusted medications based on their test results. All participants are treated for 14 days and H. pylori eradication is assessed by a breath test after 4 weeks of follow-up.
What are the possible benefits and risks of participating?
Participants in the tailored group will receive adjusted regimens based on their results of CYP2C19 polymorphism and antibiotic susceptibility that helps to reduce the risk of further treatment failure. All patients may experience side effects from taking medications such as loss of appetite, nausea, fatigue, heartburn, upset stomach, black stools, and a bitter taste.
Where is the study run from?
University Medical Center, Ho Chi Minh City (Viet Nam)
When is the study starting and how long is it expected to run for?
September 2014 to June 2017
Who is funding the study?
Department of Science and Technology of Ho Chi Minh City (Viet Nam)
Who is the main contact?
Dr Diem My Vu
diemmyvu@ump.edu.vn
Contact information
Principal Investigator
Center for Molecular Biomedicine
University of Medicine and Pharmacy at Ho Chi Minh City
217 Hong Bang St, District 5
Ho Chi Minh
70000
Viet Nam
 ORCID ID |
0000-0003-4964-2904 |
|---|---|
| Phone | +84 (0)919789811 |
| diemmyvu@ump.edu.vn |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Tailored versus conventional therapy in rescue treatment of Vietnamese patients with Helicobacter pylori: a randomized control trial |
| Study objectives | Tailored therapy has been reported to achieve a higher eradication rate than conventional therapy in treating naive patients infected with H. pylori. However, there is sparse information about its effectiveness in patients who previously failed treatment. Therefore, this study evaluated the H. pylori eradication efficacy of bismuth quadruple therapy and tailored therapy based on antibiotic susceptibility and CYP2C19 genotype of Vietnamese patients after treatment failure. |
| Ethics approval(s) | Approved 12/12/2014, The Ethics Committee of University of Medicine and Pharmacy at Ho Chi Minh City (217 Hong Bang St, District 5, Ho Chi Minh City, Vietnam; +84 (0)838535159; nghiencuukhoahoc@ump.edu.vn), ref 395/ĐHYD-HĐ |
| Health condition(s) or problem(s) studied | Helicobacter pylori infection |
| Intervention | Block randomization with a block size of 10 is used for randomly distributing participants into the two study groups. Patients are randomly assigned to the control group or the tailored group in a 1:1 ratio. The tailored group undergo a gastrointestinal endoscopy, biopsies are collected for the isolation of H. pylori and they undergo an analysis of CYP2C19 polymorphism and susceptibility testing for five antibiotics (amoxicillin, clarithromycin, levofloxacin, tetracycline, metronidazole). The conventional group receive a bismuth quadruple regimen while the tailored group is treated with adjusted medications based on their test results. All patients are treated for 2 weeks and supervised for 4 weeks after the treatment is finished. Data are collected every 2 weeks to assess patient compliance and the occurrence of side effects. A urea [14C] breath test (PY test) is performed at week 6 for determining H. pylori eradication. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Amoxicillin, clarithromycin, levofloxacin, tetracycline, metronidazole, esomeprazol, bismuth |
| Primary outcome measure | H. pylori eradication determined using a urea [14C] breath test (PY test) performed at week 6 |
| Secondary outcome measures | 1. Antibiotic resistance measured using minimum inhibitory concentration (MIC) test at the first hospital visit after patient enrolment 2. CYP2C19 polymorphism genotyping using real-time PCR and sequencing at the first hospital visit after patient enrolment |
| Overall study start date | 05/09/2014 |
| Completion date | 13/06/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 95 Years |
| Sex | Both |
| Target number of participants | 488 |
| Total final enrolment | 540 |
| Key inclusion criteria | 1. Aged 18-95 years old 2. Had a confirmed H. pylori infection by urea breath test or PY test 3. Had a history of H. pylori treatment failure |
| Key exclusion criteria | 1. Younger than 18 years old 2. Received a treatment of antibiotics, antacids, or bismuth-containing drugs within 1 month before the study 3. Had gastric cancer or gastrointestinal bleeding |
| Date of first enrolment | 01/04/2015 |
| Date of final enrolment | 31/03/2017 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Ho Chi Minh
70000
Viet Nam
Sponsor information
Government
244 Dien Bien Phu St, District 3
Ho Chi Minh
70000
Viet Nam
| Phone | +84 (0)28 39327831 |
|---|---|
| skhcn@tphcm.gov.vn | |
| Website | https://dost.hochiminhcity.gov.vn/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/09/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from Dr Diem My Vu (diemmyvu@ump.edu.vn or diemmyvu@gmail.com) on reasonable request. The data will be available for 5 years after trial completion. Other data (e.g. demographic data, health records, experimental data) collected during the trial will be available upon request and with patient agreement. |
Editorial Notes
02/03/2022: Trial's existence confirmed by the Ethics Committee of University of Medicine and Pharmacy at Ho Chi Minh City.
