H. Pylori InfectionNCT05176821
Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection
A study testing esomeprazole plus amoxicillin and amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole in people with H. Pylori Infection, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- esomeprazole plus amoxicillin and amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who were diagnosed with persistent H. pylori infection and had previously failed one or more courses of eradication therapies that included amoxicillin, clarithromycin, or nitroimidazole.
Who cannot join
- Age < 18 years old.
- The time frame was less than 6 months from the previous eradication therapy.
- The previous eradication therapy included furazolidone.
- Allergic to the medication.
- Pregnant or lactating women.
- Comorbidities of severe conditions like hepatic, renal or cardiorespiratory diseases or malignancy.
- Administration of antibiotics, bismuth or PPI in the preceding 4 weeks.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Xiamen Branch
Xiamen, 86361015
Jie CHEN, MD, 8613764633539, chen.jie5@zs@hospital.sh.cn
About this study
Official title: Eradication Efficacy and Safety of High-dose Dual Therapy Compared With Furazolidone-based Quadruple Therapy as a Rescue Treatment for Helicobacter Pylori Infection: a Randomized Controlled Trial
The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.
Read the detailed description
Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies.
- pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.
- Conditions
- H. Pylori Infection
- Being tested
- esomeprazole plus amoxicillin, amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esomeprazole plus amoxicillinDrug
Also called HDDT
amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days
amoxicillin, furazolidone, bismuth potassium citrate , esomeprazoleDrug
Also called FT
amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days
| Study group | Role | What they receive |
|---|---|---|
| High-dose dual therapy group | Experimental | esomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group Receives: Drug: esomeprazole plus amoxicillin |
| Furazolidone-based quadruple therapy | Active comparator | furazolidone 100mg bid + amoxicillin 1000mg bid + esomeprazole 20mg bid + bismuth potassium citrate 1000mg(220mg of bismuth) bid were used in the Furazolidone-based quadruple therapy Receives: Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
eradication rate
eradication rate of H pylori, presenting with negative results on the 13C-UBT test
Measured: 42 days
Secondary outcomes (2)
frequency of the adverse events
incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.
Measured: 42 days
compliance rate of the drugs
Compliance was defined as good when they had taken more than 80% of the total medication.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for H. Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Jiang, MD, Principal investigator, Xiamen branch of Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176821
- Sponsor's protocol ID
- JW-Hp2021
- Status last verified
- Aug 2022
- First submitted
- 14 Dec 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available to other researchers. We may balance the potential benefits and risks for each request and then provide the data that could be shared.
Publications
Yang J, Zhang Y, Fan L, Zhu YJ, Wang TY, Wang XW, Chen DF, Lan CH. Eradication Efficacy of Modified Dual Therapy Compared with Bismuth-Containing Quadruple Therapy as a First-Line Treatment of Helicobacter pylori. Am J Gastroenterol. 2019 Mar;114(3):437-445. doi: 10.14309/ajg.0000000000000132.
PubMed 30807294Yu L, Luo L, Long X, Liang X, Ji Y, Graham DY, Lu H. High-dose PPI-amoxicillin dual therapy with or without bismuth for first-line Helicobacter pylori therapy: A randomized trial. Helicobacter. 2019 Aug;24(4):e12596. doi: 10.1111/hel.12596. Epub 2019 May 20.
PubMed 31111580Wang C, Wang HJ, Li K, Wang Y, Lin YY, Weng CZ, Chen J, Xie SH, Jiang W, Zhu YC. Clinical Impact of High-dose Esomeprazole-amoxicillin Dual Therapy as Rescue Treatment for Helicobacter pylori Infection : A Prospective, Multicenter, Randomized Trial. J Clin Gastroenterol. 2025 Oct 1;59(9):833-841. doi: 10.1097/MCG.0000000000002100.
PubMed 39495800
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eradication Efficacy and Safety of High-dose Dual Therapy Compared With Furazolidone-based Quadruple Therapy as a Rescue Treatment for Helicobacter Pylori Infection: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05176821
- Acronym / sponsor ID
- JW-Hp2021
- Conditions
- H. Pylori Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 4 Jan 2022 (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.
The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.
Detailed description
Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies.
- pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose dual therapy group | Experimental | Drug: esomeprazole plus amoxicillinesomeprazole 20mg qid plus amoxicillin 750mg qid were used in the high-dose dual therapy group |
| Furazolidone-based quadruple therapy | Active comparator | Drug: amoxicillin, furazolidone, bismuth potassium citrate , esomeprazolefurazolidone 100mg bid + amoxicillin 1000mg bid + esomeprazole 20mg bid + bismuth potassium citrate 1000mg(220mg of bismuth) bid were used in the Furazolidone-based quadruple therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients who were diagnosed with persistent H. pylori infection and had previously failed one or more courses of eradication therapies that included amoxicillin, clarithromycin, or nitroimidazole.
Key exclusion criteria (7 listed)
- Age < 18 years old.
- The time frame was less than 6 months from the previous eradication therapy.
- The previous eradication therapy included furazolidone.
- Allergic to the medication.
- Pregnant or lactating women.
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 |
|---|---|---|
| esomeprazole plus amoxicillinAlso: HDDTamoxicillin 750mg QID + esomeprazole 20mg QID for 14 days | Drug | High-dose dual therapy group |
| amoxicillin, furazolidone, bismuth potassium citrate , esomeprazoleAlso: FTamoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days | Drug | Furazolidone-based quadruple therapy |
Primary outcome
eradication rate
Time frame: 42 days
eradication rate of H pylori, presenting with negative results on the 13C-UBT test
2 secondary outcomes
frequency of the adverse events
Time frame: 42 days
compliance rate of the drugs
Time frame: 42 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Background: PubMed 30807294Yang J, Zhang Y, Fan L, Zhu YJ, Wang TY, Wang XW, Chen DF, Lan CH. Eradication Efficacy of Modified Dual Therapy Compared with Bismuth-Containing Quadruple Therapy as a First-Line Treatment of Helicobacter pylori. Am J Gastroenterol. 2019 Mar;114(3):437-445. doi: 10.14309/ajg.0000000000000132.
- Background: PubMed 31111580Yu L, Luo L, Long X, Liang X, Ji Y, Graham DY, Lu H. High-dose PPI-amoxicillin dual therapy with or without bismuth for first-line Helicobacter pylori therapy: A randomized trial. Helicobacter. 2019 Aug;24(4):e12596. doi: 10.1111/hel.12596. Epub 2019 May 20.
- Derived from this study: PubMed 39495800Wang C, Wang HJ, Li K, Wang Y, Lin YY, Weng CZ, Chen J, Xie SH, Jiang W, Zhu YC. Clinical Impact of High-dose Esomeprazole-amoxicillin Dual Therapy as Rescue Treatment for Helicobacter pylori Infection : A Prospective, Multicenter, Randomized Trial. J Clin Gastroenterol. 2025 Oct 1;59(9):833-841. doi: 10.1097/MCG.0000000000002100.
- Individual participant dataSharing planned: Yes. Individual participant data will be available to other researchers. We may balance the potential benefits and risks for each request and then provide the data that could be shared.
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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.
Wei Jiang, MD principal investigator
Xiamen branch of Zhongshan Hospital, Fudan University
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 plus amoxicillin and amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole in people with H. Pylori Infection, run by Shanghai Zhongshan Hospital 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 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 5 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Chen, MD (8613764633539, chen.jie5@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eradication rate (time frame: 42 days). 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 NCT05176821, 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 5 Aug 2022.