GastritisPhase 4NCT05742568
Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology
A Phase 4 study testing Esomeprazole, Amoxicillin and Bismuth in people with Gastritis and Dyspepsia, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
This study was conducted to investigate the effects of high-dose diphtherapy and bismuth quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the changes in intestinal microbiota diversity and structure before and after the two treatment regimens, and to explore the relationship between… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastritis, Dyspepsia, Helicobacter Pylori Infection
- What is being tested?
- Esomeprazole, Amoxicillin and Bismuth
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 10 Mar 2024
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years, regardless of gender.
- Patients with definite Hp infection (positive for either 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) and who have not received H. pylori eradication therapy.
- Voluntary Hp eradication therapy.
- Women of childbearing potential are required to use a medically advisable form of contraception during the trial and for 30 days after the trial ends.
Who cannot join
- Patients who have had a definite diagnosis of Hp infection and have been treated with antibiotic eradication therapy.
- Patients with contraindications to or allergies to the study drug.
- Patients with severe organ damage and complications (e.g., cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease
- Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (taken at least 2 weeks prior to the screening for Hp infection)
- Pregnant and lactating women.
- Having undergone upper gastrointestinal surgery.
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- Have symptoms of dysphagia.
- Evidence of bleeding or iron deficiency anemia.
- History of malignancy.
- History of drug or alcohol abuse within the last 1 year.
- Systemic application of glucocorticoids, non-steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except for the use of aspirin ≤100 mg/d)
- Those with psychiatric disorders.
- Received other clinical trials within the past 3 months
- Refusal to sign the informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to investigate the effects of high-dose diphtherapy and bismuth quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the changes in intestinal microbiota diversity and structure before and after the two treatment regimens, and to explore the relationship between different treatment regimens and intestinal microbiota dysbiosis; to further guide the safety and drug resistance of H. pylori eradication by the two treatment regimens. The expected results are to observe the changes of intestinal microbiota diversity and structure before and after treatment with the two treatment regimens.
Read the detailed description
The trial can be divided into three phases.
- Enrollment screening phase: patients who had been clearly diagnosed with Hp infection and had not received antibiotic therapy and met the inclusion and exclusion criteria were informed and signed informed consent forms, their basic data information was collected, medical history and laboratory tests before enrollment were taken; if they met the requirements of the trial protocol they were included in the study, and patients' stools were collected for 16S rRNA gene sequencing.
- Treatment period: Patients were enrolled according to a randomized number table provided in advance by a third party, and patients were randomized in a 1:1 ratio to high-dose diphtherapy and bismuth quadruple therapy to receive 2 weeks of Hp eradication treatment. During the treatment period, patients were provided with written instructions on how to take the medication, instructed on the correct way to take the medication, and improved their compliance; patients were asked to record their symptoms and adverse reactions during the medication period, and were informed of the visiting telephone number and visiting WeChat, so that they could keep in touch with the investigator at any time.
- Follow-up period: At the end of treatment (i.e., day 14 from the start of treatment), patients were asked to return at that time to have their stools sequenced for 16S rRNA gene, and 6 weeks after the end of treatment (i.e., day 56 from the start of treatment), patients were asked to return at that time to undergo rapid urease test (RUT), 13C/14C-urea breath test (13C/14C-UBT), or fecal Hp antigen test. ) or fecal Hp antigen assay (HpSA), with the results recorded on a CRF form, and the patient's stool collected for 16S rRNA gene sequencing.
- Being tested
- Esomeprazole, Amoxicillin, Bismuth, Clarithromycin
- Keywords
- Helicobacter pylori, High-dose dual therapy, Bismuth-combining quadruple therapy, Intestinal Microecology
- Medical subject headings
- Gastritis, Dyspepsia, Stomach Neoplasms, Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsomeprazoleDrug
Also called Nexium
High-dose dual therapy: given for 14 days at a dose of esomeprazole 20mg 2 tablet TID plus amoxicillin 500 mg 2 capsules TID
AmoxicillinDrug
Also called Amoxy
High-dose dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 20mg 2 tablet TID
BismuthDrug
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID
EsomeprazoleDrug
Also called Nexium
BBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID
AmoxicillinDrug
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID
ClarithromycinDrug
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID
| Study group | Role | What they receive |
|---|---|---|
| High-dose dual therapy | Experimental | Esomeprazole Enteric Tablets 40mg, 3 times/day; Amoxicillin Capsules 1000mg, 3 times/day.The course of all drugs is two weeks. Receives: Drug: Esomeprazole; Drug: Amoxicillin |
| Bismuth Quadruple Therapy | Active comparator | Esomeprazole Enteric Tablets 40mg, 2 times/day; Amoxicillin Capsules 1000mg, 2 times/day; Clarithromycin Tablets 500mg, 2 times/day; Colloidal Bismuth Tartrate Capsules 220mg, 2 times/day.The course of all drugs is two weeks. Receives: Drug: Bismuth; Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the diversity and structure of fecal microbiota
Feces from subjects before treatment , after eradication treatment , and at week 6 after eradication treatment were analyzed for gut microbiota diversity by 16S rRNA gene sequencing, including alpha diversity (representing the abundance of species in the microbial ecosystem, i.e., the number of different species, and evenness, i.e., similar abundance or dominance of some species over others) and beta diversity (representing the difference in microbial composition in one environment compared to another).We will explore the changes in intestinal microbiota diversity and structure before and after treatment with both treatment regimens.
Measured: before treatment,1day after treatment,6 weeks after treatment
Secondary outcomes (1)
Eradication rate of Helicobacter pylori
The end point of this study is H.pylori eradication，established by negative [13C] urea breath test （DOB value below 3.9）28 days after the end of eradication.
Measured: 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start1 Dec 2022
- Primary completion2 Dec 2023
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies of the same condition, open and under way.
- 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
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
- Investigators
- Yongquan Shi, Ph. D, Study director, Xijing Hosipital of Digestive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742568
- Sponsor's protocol ID
- KY20222310-C-1
- Status last verified
- Jul 2025
- First submitted
- 3 Feb 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-dose Dual Therapy and Bismuth Quadruple Therapy for Helicobacter Pylori Eradication on Intestinal Microecology
- ClinicalTrials.gov ID
- NCT05742568
- Acronym / sponsor ID
- KY20222310-C-1
- Keywords
- Helicobacter pylori, High-dose dual therapy, Bismuth-combining quadruple therapy, Intestinal Microecology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 2 Dec 2023 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 24 Feb 2023 (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.
This study was conducted to investigate the effects of high-dose diphtherapy and bismuth quadruple therapy on H. pylori eradication on intestinal microecology, to clarify the changes in intestinal microbiota diversity and structure before and after the two treatment regimens, and to explore the relationship between different treatment regimens and intestinal microbiota dysbiosis; to further guide the safety and drug resistance of H. pylori eradication by the two treatment regimens. The expected results are to observe the changes of intestinal microbiota diversity and structure before and after treatment with the two treatment regimens.
Detailed description
The trial can be divided into three phases.
- Enrollment screening phase: patients who had been clearly diagnosed with Hp infection and had not received antibiotic therapy and met the inclusion and exclusion criteria were informed and signed informed consent forms, their basic data information was collected, medical history and laboratory tests before enrollment were taken; if they met the requirements of the trial protocol they were included in the study, and patients' stools were collected for 16S rRNA gene sequencing.
- Treatment period: Patients were enrolled according to a randomized number table provided in advance by a third party, and patients were randomized in a 1:1 ratio to high-dose diphtherapy and bismuth quadruple therapy to receive 2 weeks of Hp eradication treatment. During the treatment period, patients were provided with written instructions on how to take the medication, instructed on the correct way to take the medication, and improved their compliance; patients were asked to record their symptoms and adverse reactions during the medication period, and were informed of the visiting telephone number and visiting WeChat, so that they could keep in touch with the investigator at any time.
- Follow-up period: At the end of treatment (i.e., day 14 from the start of treatment), patients were asked to return at that time to have their stools sequenced for 16S rRNA gene, and 6 weeks after the end of treatment (i.e., day 56 from the start of treatment), patients were asked to return at that time to undergo rapid urease test (RUT), 13C/14C-urea breath test (13C/14C-UBT), or fecal Hp antigen test. ) or fecal Hp antigen assay (HpSA), with the results recorded on a CRF form, and the patient's stool collected for 16S rRNA gene sequencing.
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 | Experimental | Drug: Esomeprazole, Drug: AmoxicillinEsomeprazole Enteric Tablets 40mg, 3 times/day; Amoxicillin Capsules 1000mg, 3 times/day.The course of all drugs is two weeks. |
| Bismuth Quadruple Therapy | Active comparator | Drug: Bismuth, Drug: Esomeprazole, Drug: Amoxicillin, Drug: ClarithromycinEsomeprazole Enteric Tablets 40mg, 2 times/day; Amoxicillin Capsules 1000mg, 2 times/day; Clarithromycin Tablets 500mg, 2 times/day; Colloidal Bismuth Tartrate Capsules 220mg, 2 times/day.The course of all drugs is two weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 to 70 years, regardless of gender.
- Patients with definite Hp infection (positive for either 13C/14C urea breath test, rapid urease test, and fecal Hp antigen test) and who have not received H. pylori eradication therapy.
- Voluntary Hp eradication therapy.
- Women of childbearing potential are required to use a medically advisable form of contraception during the trial and for 30 days after the trial ends.
Key exclusion criteria (14 listed)
- Patients who have had a definite diagnosis of Hp infection and have been treated with antibiotic eradication therapy.
- Patients with contraindications to or allergies to the study drug.
- Patients with severe organ damage and complications (e.g., cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine disease
- Continuous use of anti-ulcer drugs, antibiotics or bismuth complexes (taken at least 2 weeks prior to the screening for Hp infection)
- Pregnant and 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 |
|---|---|---|
| EsomeprazoleAlso: NexiumHigh-dose dual therapy: given for 14 days at a dose of esomeprazole 20mg 2 tablet TID plus amoxicillin 500 mg 2 capsules TID | Drug | High-dose dual therapy |
| AmoxicillinAlso: AmoxyHigh-dose dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 20mg 2 tablet TID | Drug | High-dose dual therapy |
| BismuthBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID | Drug | Bismuth Quadruple Therapy |
| EsomeprazoleAlso: NexiumBBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID | Drug | Bismuth Quadruple Therapy |
| AmoxicillinBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID | Drug | Bismuth Quadruple Therapy |
| ClarithromycinBismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 20 mg 2 tablets BID, amoxicillin 500mg 2 capsules BID and clarithromycin 250mg 2 tablets BID | Drug | Bismuth Quadruple Therapy |
Primary outcome
Changes in the diversity and structure of fecal microbiota
Time frame: before treatment,1day after treatment,6 weeks after treatment
Feces from subjects before treatment , after eradication treatment , and at week 6 after eradication treatment were analyzed for gut microbiota diversity by 16S rRNA gene sequencing, including alpha diversity (representing the abundance of species in the microbial ecosystem, i.e., the number of different species, and evenness, i.e., similar abundance or dominance of some species over others) and beta diversity (representing the difference in microbial composition in one environment compared to another).We will explore the changes in intestinal microbiota diversity and structure before and after treatment with both treatment regimens.
1 secondary outcome
Eradication rate of Helicobacter pylori
Time frame: 28 days after treatment
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 3 Jul 2025.
- 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.
Yongquan Shi, Ph. D study director
Xijing Hosipital of Digestive Disease
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 Esomeprazole, Amoxicillin and Bismuth in people with Gastritis and Dyspepsia, run by Xijing Hospital of Digestive Diseases 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 4 inclusion and 14 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 3 Jul 2025. 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.
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?
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?
Changes in the diversity and structure of fecal microbiota (time frame: before treatment,1day after treatment,6 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2025.