Helicobacter Pylori InfectionNCT06332599
Minocycline for Helicobacter Pylori Rescue Treatment
An observational study of Helicobacter Pylori Infection, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. 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?
- BQT, PBM4M4 and PBM3M3
- How many people
- 823 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 30 Apr 2024
- Phase
- Observational
- 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
Study population: All patients who failed at least two courses of H. pylori treatment containing clarithromycin, nitroimidazoles, fluoroquinolones, and/or amoxicillin, and received 14-day tetracycline/minocycline, metronidazole-containing bismuth quadruple therapy were identified. Patients with the following criteria were excluded: (1) naive to H. pylori treatment; (2) under 18 or over 80 years; (3) history of gastrectomy; (4) administration of antibiotics, bismuth, acid suppressants, or Chinese herb medicine in the preceding 12 weeks; (5) severe systemic diseases or malignancy.
Who may be able to join
- Confirmed H. pylori infection and with previous treatment failure
Who cannot join
- subjects naive to H. pylori treatment,
- history of gastrectomy
- pregnant or lactating women
- severe systemic diseases or malignancy
- administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 12 weeks
Trial locations and contacts
1 site in 1 country.
China1 site
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, None Selected, 200127
About this study
Official title: Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Real-world Evidence Study
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- BQT, PBM4M4, PBM3M3, PBM2M4, PBM2M3
- Keywords
- Helicobacter pylori, rescue therapy, minocycline
- Medical subject headings
- cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BQTDrug
PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, tetracycline 500 mg four times a day, and metronidazole 400 mg four times a day
PBM4M4Drug
PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg four times a day, and metronidazole 400 mg four times a day
PBM3M3Drug
PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg three times a day, and metronidazole 400 mg three times a day
PBM2M4Drug
PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg twice daily, and metronidazole 400 mg four times a day
PBM2M3Drug
PPI（esomeprazole or vonoprazan), bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg twice daily, and metronidazole 400 mg three times a day
| Study group | Role | What they receive |
|---|---|---|
| BQT | Not described Receives: Drug: BQT | |
| PBM4M4 | Not described Receives: Drug: PBM4M4 | |
| PBM3M3 | Not described Receives: Drug: PBM3M3 | |
| PBM2M4 | Not described Receives: Drug: PBM2M4 | |
| PBM2M3 | Not described Receives: Drug: PBM2M3 |
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 defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
Measured: Six weeks after completion of therapy
Secondary outcomes (2)
Rate of adverse effects
The subjects were asked to grade the severity of adverse events according to their influence on daily activities, experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with daily activities), or "severe" (causing considerable interference with daily activities)
Measured: Within six weeks after completion of therapy
Compliance rate
Compliance was defined as poor when they had taken less than 80% of the total medication
Measured: Within six weeks 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 posted27 Mar 2024
- Study start1 Mar 2021
- Primary completion30 Mar 2024
- Study completion30 Apr 2024
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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 823 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, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332599
- Sponsor's protocol ID
- rjhy20240001
- Status last verified
- May 2024
- First submitted
- 17 Mar 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Y, Qiu S, Guo Y, Chen J, Li M, Ding Z, Zhang W, Liang X, Lu H. Optimization of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Real-World Evidence Study. Helicobacter. 2024 Sep-Oct;29(5):e13138. doi: 10.1111/hel.13138.
PubMed 39306798
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minocycline-containing Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: a Real-world Evidence Study
- ClinicalTrials.gov ID
- NCT06332599
- Acronym / sponsor ID
- rjhy20240001
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, rescue therapy, minocycline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 823 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 27 Mar 2024 (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.
Current guidelines have recommended classical bismuth-containing quadruple therapy including proton-pump inhibitor, bismuth, tetracycline, metronidazole as the empirical rescue therapy. However, tetracycline is clinically unavailable in China and the high frequency of adverse events of bismuth quadruple therapy often result in poor compliance, which limited the applicability of this recommendation. We previously showed that the efficacy of bismuth-containing quadruple therapy with minocycline and metronidazole was not inferior to classical bismuth quadruple therapy for refractory H. pylori infection, though also accompanied with high occurrence of adverse events.This study aimed to evaluate the efficacy and tolerability of four different regimens with minocycline and metronidazole compared to classical bismuth quadruple therapy for H. pylori rescue treatment in a real-world setting.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| BQT | – | Drug: BQT |
| PBM4M4 | – | Drug: PBM4M4 |
| PBM3M3 | – | Drug: PBM3M3 |
| PBM2M4 | – | Drug: PBM2M4 |
| PBM2M3 | – | Drug: PBM2M3 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who failed at least two courses of H. pylori treatment containing clarithromycin, nitroimidazoles, fluoroquinolones, and/or amoxicillin, and received 14-day tetracycline/minocycline, metronidazole-containing bismuth quadruple therapy were identified. Patients with the following criteria were excluded: (1) naive to H. pylori treatment; (2) under 18 or over 80 years; (3) history of gastrectomy; (4) administration of antibiotics, bismuth, acid suppressants, or Chinese herb medicine in the preceding 12 weeks; (5) severe systemic diseases or malignancy.
Key inclusion criteria (1 listed)
- Confirmed H. pylori infection and with previous treatment failure
Key exclusion criteria (5 listed)
- subjects naive to H. pylori treatment,
- history of gastrectomy
- pregnant or lactating women
- severe systemic diseases or malignancy
- administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 12 weeks
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 |
|---|---|---|
| BQTPPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, tetracycline 500 mg four times a day, and metronidazole 400 mg four times a day | Drug | BQT |
| PBM4M4PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg four times a day, and metronidazole 400 mg four times a day | Drug | PBM4M4 |
| PBM3M3PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg three times a day, and metronidazole 400 mg three times a day | Drug | PBM3M3 |
| PBM2M4PPI（esomeprazole or vonoprazan) 20 mg twice daily, bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg twice daily, and metronidazole 400 mg four times a day | Drug | PBM2M4 |
| PBM2M3PPI（esomeprazole or vonoprazan), bismuth potassium citrate 600 mg (220 mg elemental bismuth) twice daily, minocycline 50 mg twice daily, and metronidazole 400 mg three times a day | Drug | PBM2M3 |
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 defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
2 secondary outcomes
Rate of adverse effects
Time frame: Within six weeks after completion of therapy
Compliance rate
Time frame: Within six weeks 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 30 Dec 2024.
- Derived from this study: PubMed 39306798Huang Y, Qiu S, Guo Y, Chen J, Li M, Ding Z, Zhang W, Liang X, Lu H. Optimization of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter pylori Rescue Treatment: A Real-World Evidence Study. Helicobacter. 2024 Sep-Oct;29(5):e13138. doi: 10.1111/hel.13138.
- Individual participant dataSharing planned: No
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
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
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
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?
An observational study of 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 1 inclusion and 5 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 30 Dec 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 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 NCT06332599, 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 Dec 2024.