Helicobacter Pylori InfectionNCT04879992
Rifabutin-containing Triple Therapy for Treatment of Helicobacter Pylori
A study testing Esomeprazole, Bismuth Potassium Citrate and Tetracycline,Metronidazole in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Esomeprazole, Bismuth Potassium Citrate and Tetracycline,Metronidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 413 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2021to 30 Oct 2022
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection and with previous treatment experience
Who cannot join
- Less than 18 years old
- With previous gastric surgery
- Previous history of tuberculosis
- Major systemic diseases
- Pregnancy or lactation
- Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
About this study
Official title: Rifabutin-containing Triple Therapy for Rescue Treatment of Helicobacter Pylori: A Randomized Clinical Trial
Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Esomeprazole, Bismuth Potassium Citrate, Tetracycline,Metronidazole, amoxicillin rifabutin
- Keywords
- Helicobacter pylori Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Proton pump inhibitor
Bismuth Potassium CitrateDrug
Gastric mucosal protective drug with anti-H. pylori effect
Tetracycline,MetronidazoleDrug
Antibiotics for H. pylori eradication
amoxicillin rifabutinDrug
Antibiotics for H. pylori eradication
| Study group | Role | What they receive |
|---|---|---|
| Tetracycline Bismuth Quadruple Therapy | Active comparator | Esomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid Receives: Drug: Esomeprazole; Drug: Bismuth Potassium Citrate; Drug: Tetracycline,Metronidazole |
| rifabutin triple therapy | Experimental | Esomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid Receives: Drug: Esomeprazole; Drug: amoxicillin rifabutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication rate
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was
Measured: Six weeks after completion of therapy
Secondary outcomes (1)
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication
Measured: Within 7 days after completion of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start7 May 2021
- Primary completion14 Oct 2022
- Study completion30 Oct 2022
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 Shanghai Jiao Tong University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 413 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04879992
- Sponsor's protocol ID
- rjcjn20210506
- Status last verified
- Nov 2022
- First submitted
- 6 May 2021
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen J, Guo Y, Huang Y, Ding Z, Wang J, Liang X, Xu P, Han Y, Lu H. Rifabutin-Containing Triple Therapy Versus Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Multicenter, Randomized Controlled Trial. J Infect Dis. 2023 Aug 31;228(5):511-518. doi: 10.1093/infdis/jiad114.
PubMed 37079894
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifabutin-containing Triple Therapy for Rescue Treatment of Helicobacter Pylori: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04879992
- Acronym / sponsor ID
- rjcjn20210506
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 7 May 2021 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 10 May 2021 (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.
Rifabutin has good chemical stability and low drug resistance rate in acidic gastric environment. Therefore, it is often used in combination with amoxicillin proton pump inhibitor for the rescue treatment of Helicobacter pylori. The purpose of this study was to evaluate the efficacy and safety of rifabutin-containing triple therapy versus classical bismuth-containing quadruple therapy as rescue therapy for the eradication of refractory Helicobacter pylori
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tetracycline Bismuth Quadruple Therapy | Active comparator | Drug: Esomeprazole, Drug: Bismuth Potassium Citrate, Drug: Tetracycline,MetronidazoleEsomeprazole 20mg bid, Bismuth Potassium Citrate 300mg bid, Tetracycline 500mg qid, Metronidazole 400mg qid |
| rifabutin triple therapy | Experimental | Drug: Esomeprazole, Drug: amoxicillin rifabutinEsomeprazole 20mg bid, amoxicillin 1000mg bid, rifabutin 150mg bid |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ability and willingness to participate in the study and to sign and give informed consent
- Confirmed H. pylori infection and with previous treatment experience
Key exclusion criteria (6 listed)
- Less than 18 years old
- With previous gastric surgery
- Previous history of tuberculosis
- Major systemic diseases
- Pregnancy or lactation
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 |
|---|---|---|
| EsomeprazoleProton pump inhibitor | Drug | Tetracycline Bismuth Quadruple Therapy, rifabutin triple therapy |
| Bismuth Potassium CitrateGastric mucosal protective drug with anti-H. pylori effect | Drug | Tetracycline Bismuth Quadruple Therapy |
| Tetracycline,MetronidazoleAntibiotics for H. pylori eradication | Drug | Tetracycline Bismuth Quadruple Therapy |
| amoxicillin rifabutinAntibiotics for H. pylori eradication | Drug | rifabutin triple therapy |
Primary outcome
Helicobacter pylori eradication rate
Time frame: Six weeks after completion of therapy
Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was
1 secondary outcome
Compliance rate
Time frame: Within 7 days after completion of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 37079894Chen J, Guo Y, Huang Y, Ding Z, Wang J, Liang X, Xu P, Han Y, Lu H. Rifabutin-Containing Triple Therapy Versus Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Multicenter, Randomized Controlled Trial. J Infect Dis. 2023 Aug 31;228(5):511-518. doi: 10.1093/infdis/jiad114.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esomeprazole, Bismuth Potassium Citrate and Tetracycline,Metronidazole in people with Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 2 inclusion and 6 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 15 Nov 2022. 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 China. 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.
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?
Helicobacter pylori eradication rate (time frame: Six weeks after completion of therapy). 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 NCT04879992, 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 15 Nov 2022.