HELICOBACTER PYLORI INFECTIONSPhase 4NCT07897994
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
A Phase 4 study testing Linalarose Glutarate and Bismuth Quadruple Test in people with HELICOBACTER PYLORI INFECTIONS, run by Yongquan Shi at 24 sites in China.
Trial summary
This clinical trial aims to compare the efficacy of the dual therapy regimen of linralase glutarate capsules and amoxicillin versus the quadruple therapy regimen containing bismuth for the first-line eradication of Helicobacter pylori infection. The primary questions this trial aims to address include: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Linalarose Glutarate and Bismuth Quadruple Test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 24 sitesChina
- Study dates
- 1 Oct 2026to 30 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- (1) Adult patients aged 18-70 years, regardless of gender;
- (2) Patients diagnosed with Helicobacter pylori infection via 13C/14C-UBT;
- (3) Patients who have not previously undergone Helicobacter pylori eradication therapy;
- (4) Patients who have provided informed consent and voluntarily agreed to participate in this study.
Who cannot join
- (1) Individuals allergic to the study drug;
- (2) Individuals who have taken antibiotics, bismuth-containing agents, probiotics, or traditional Chinese medicines with antibacterial activity within the past 4 weeks;
- (3) Individuals who have taken P-CAB, PPI, or H2 receptor antagonists within the past 2 weeks;
- (4) Individuals with a history of failed Helicobacter pylori eradication therapy;
- (5) Women who are pregnant, breastfeeding, or planning to become pregnant;
- (6) Patients with concomitant peptic ulcers, reflux esophagitis, MALT lymphoma, gastrointestinal malignancies, or those who have undergone esophageal or gastric surgery;
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- (7) Patients with severe cardiac, hepatic, pulmonary, or renal diseases, or those with impaired immunity;
- (8) Patients unable to comply with treatment due to alcohol abuse, substance abuse, or severe mental illness;
- (9) Patients requiring treatment with atazanavir, nelfinavir, or rilpivirine.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing
Zhai, 86-010-83922345, xwyygcplx@xwh.ccmu.edu.cn
- Recruiting
Yuanzhang@Mail.Tsinghua.Edu.Cn
Beijing
Song, 86-010-89926000, yuanzhang@mail.tsinghua.edu.cn
- Recruiting
Chongqing General Hospital
Chongqing
Song, 86-023-63390060, 442139247@qq.com
- Recruiting
The Sixth Affiliated Hospital of South China University of Technology
Foshan
Lun, 86-0757-89932927, nhrmyy@126.com
- Recruiting
Fuzhou Traditional Chinese Medicine Hospital
Fujian
Zhenwen Lin, 86-0591-87678569, fzszyy@126.com
- Recruiting
Guangdong General Hospita
Guangzhou
Weihong Sha, 86-020-83827812, gdghospital_ec@gdph.org.cn
- Recruiting
PLA General Hospital No. 962
Ha’erbin
Chen, 86-0451-86666491, 15114565989@163.com
- Recruiting
The First Affiliated Hospital of HarbinMedical University
Ha’erbin
Hongyu Xu, 86-0451-85552816, 13624612942@163.com
- Recruiting
The First Affiliated Hospital of Henan University of Medicine
Henan
Chang, 86-0373-4402079, lunli1896@126.com
- Recruiting
Affiliated Hospital of Chengde Medical University
Jiangxi
He, 86-0314-2279656, cyfyts@163.com
- Recruiting
First Affiliated Hospital of Gannan Medical University
Jiangxi
Xie, 86+0797-8266000, gyfyjjjcs@163.com
- Recruiting
The First People's Hospital of Jingzhou
Jingzhou
zhang, +86-0716-8111848, jzyyywll@126.com
- Recruiting
Longyan First Hospital
Longyan
Xu, 86-0597-3102900, 442139247@qq.com
- Recruiting
Shandong University of Traditional Chinese Medicine
Shandong
Jia, 86-0531-68616733, keyanke6236@163.com
- Recruiting
The Second Hospital of Shandong University
Shandong
Wu, 86-0531-85875025, sdeylunli@126.com
- Recruiting
General Hospital of Chengdu Military Command of PLA
Sichuan
Shanhong Tang, 86-4006-9966-81, 1549957449@QQ.com
- Recruiting
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Sichuan
Caiping Gao, 86-028-87393999, cshlb@163.com
- Recruiting
Taiyuan Iron and Steel (Group)
Taiyuan
Jia, 86+0351-2133007, tgllwyh@163.com
- Recruiting
Wenzhou Central Hospital
Wenzhou, Zhejiang
Jiejun Lin, 86-0577-88882121, weybgs@163.com
- Recruiting
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710005
Lu Li, 86-029-84771535, von15991351319@163.com
- Recruiting
Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, 710005
Yongquan Shi, Ph. D, 86-029-84771535, von15991351319@163.com
- Recruiting
Xuzhou Central Hospital
Xuzhou
Haiyan Zhang, 0516-96120, sylunli@163.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Hui Ding, 86-0371-61626650, b65580013@vip.163.com
- Recruiting
The First Affiliated Hospital of ZhengzhouUniversity
Zhengzhou, Henan
Hongtao Wen, 86-0373-66913114, Yuanban3031@163.com
About this study
Official title: 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: A Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Controlled Study
This clinical trial aims to compare the efficacy of the dual therapy regimen of linralase glutarate capsules and amoxicillin versus the quadruple therapy regimen containing bismuth for the first-line eradication of Helicobacter pylori infection. The primary questions this trial aims to address include: 1. Whether the linalarenate glutarate capsule-amoxicillin dual-drug regimen is non-inferior to the bismuth-containing quadruple therapy, while simultaneously evaluating patient adherence and the incidence of adverse events in both treatment groups. Participants will: 1. Treatment group: Linaralate Glutarate Capsules (50 mg bid) + Amoxicillin (1 g tid), for a 14-day treatment course. 2. Control group: Esomeprazole 20 mg, twice daily (bid) + clarithromycin 0.5 g, twice daily (bid) + amoxicillin 1 g, twice daily (bid) + colloidal bismuth subcitrate 200 mg, twice daily (bid), for a 14-day treatment course. The primary endpoint is the Helicobacter pylori eradication rate 4 weeks after discontinuation of treatment.
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Being tested
- Linalarose Glutarate, Bismuth Quadruple Test
- Keywords
- HELICOBACTER PYLORI INFECTIONS, Linalarose Glutarate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linalarose GlutarateDrug
Glutaric acid linalaric acid ester capsules (50 mg bid) + amoxicillin (1 g tid), for a 14-day course.
Bismuth Quadruple TestDrug
Esomeprazole 20 mg, twice daily (bid) + clarithromycin 0.5 g, twice daily (bid) + amoxicillin 1 g, twice daily (bid) + colloidal bismuth subcitrate 200 mg, twice daily (bid), for a 14-day treatment course.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Glutaric acid linalaric acid ester capsules (50 mg bid) + amoxicillin (1 g tid), for a 14-day course. Receives: Drug: Linalarose Glutarate |
| Control group | Active comparator | Esomeprazole 20 mg, twice daily (bid) + clarithromycin 0.5 g, twice daily (bid) + amoxicillin 1 g, twice daily (bid) + colloidal bismuth subcitrate 200 mg, twice daily (bid), for a 14-day treatment course. Receives: Drug: Bismuth Quadruple Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Helicobacter pylori eradication
The primary 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
Secondary outcomes (1)
adverse events
Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain.
Measured: 14 days of treatment, and 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 posted27 Oct 2026
- Study start1 Oct 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies 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
- 448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yongquan Shi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897994
- Sponsor's protocol ID
- KY20262364-F-1
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang XP, Liu YJ, Lin SW, Shao YF, Qiu F, Qiu QW, Xu ZK, Chen JX, Chen LH, Lin ZQ, Dai WH, Zhang MQ, Jiang Q, Xiao ZQ, Cheng XX, Zhang XF, You WB, Chen W, Li LQ, Lin WX, Wang YF, Lai FJ, Chen LQ, Huang ZH, Zheng WQ, Wei JQ, Lin ZH. Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population: A prospective, multicenter, randomized, two-stage study. World J Gastroenterol. 2024 Jul 21;30(27):3304-3313. doi: 10.3748/wjg.v30.i27.3304.
PubMed 39086752Song Z, Zuo X, Zhang Z, Wang X, Lin Y, Li Y, Xu X, Huang Y, Wang Q, Shi Y, Zhou L. Ten-Day Versus 14-Day Vonoprazan and Amoxicillin Dual Therapy for the Firstline Eradication of Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial. Helicobacter. 2025 Sep-Oct;30(5):e70070. doi: 10.1111/hel.70070.
PubMed 40908593
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: A Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Controlled Study
- ClinicalTrials.gov ID
- NCT07897994
- Acronym / sponsor ID
- KY20262364-F-1
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- HELICOBACTER PYLORI INFECTIONS, Linalarose Glutarate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 448 participants (estimated)
- Lead sponsor
- Yongquan ShiUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 27 Oct 2026 (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 clinical trial aims to compare the efficacy of the dual therapy regimen of linralase glutarate capsules and amoxicillin versus the quadruple therapy regimen containing bismuth for the first-line eradication of Helicobacter pylori infection. The primary questions this trial aims to address include: 1. Whether the linalarenate glutarate capsule-amoxicillin dual-drug regimen is non-inferior to the bismuth-containing quadruple therapy, while simultaneously evaluating patient adherence and the incidence of adverse events in both treatment groups. Participants will: 1. Treatment group: Linaralate Glutarate Capsules (50 mg bid) + Amoxicillin (1 g tid), for a 14-day treatment course. 2. Control group: Esomeprazole 20 mg, twice daily (bid) + clarithromycin 0.5 g, twice daily (bid) + amoxicillin 1 g, twice daily (bid) + colloidal bismuth subcitrate 200 mg, twice daily (bid), for a 14-day treatment course. The primary endpoint is the Helicobacter pylori eradication rate 4 weeks after discontinuation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Linalarose GlutarateGlutaric acid linalaric acid ester capsules (50 mg bid) + amoxicillin (1 g tid), for a 14-day course. |
| Control group | Active comparator | Drug: Bismuth Quadruple TestEsomeprazole 20 mg, twice daily (bid) + clarithromycin 0.5 g, twice daily (bid) + amoxicillin 1 g, twice daily (bid) + colloidal bismuth subcitrate 200 mg, twice daily (bid), for a 14-day treatment course. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (1) Adult patients aged 18-70 years, regardless of gender;
- (2) Patients diagnosed with Helicobacter pylori infection via 13C/14C-UBT;
- (3) Patients who have not previously undergone Helicobacter pylori eradication therapy;
- (4) Patients who have provided informed consent and voluntarily agreed to participate in this study.
Key exclusion criteria (9 listed)
- (1) Individuals allergic to the study drug;
- (2) Individuals who have taken antibiotics, bismuth-containing agents, probiotics, or traditional Chinese medicines with antibacterial activity within the past 4 weeks;
- (3) Individuals who have taken P-CAB, PPI, or H2 receptor antagonists within the past 2 weeks;
- (4) Individuals with a history of failed Helicobacter pylori eradication therapy;
- (5) Women who are pregnant, breastfeeding, or planning to become pregnant;
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 |
|---|---|---|
| Linalarose GlutarateGlutaric acid linalaric acid ester capsules (50 mg bid) + amoxicillin (1 g tid), for a 14-day course. | Drug | Treatment group |
| Bismuth Quadruple TestEsomeprazole 20 mg, twice daily (bid) + clarithromycin 0.5 g, twice daily (bid) + amoxicillin 1 g, twice daily (bid) + colloidal bismuth subcitrate 200 mg, twice daily (bid), for a 14-day treatment course. | Drug | Control group |
Primary outcome
Helicobacter pylori eradication
Time frame: 28 days after treatment
The primary 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
1 secondary outcome
adverse events
Time frame: 14 days of treatment, and 28 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 39086752Huang XP, Liu YJ, Lin SW, Shao YF, Qiu F, Qiu QW, Xu ZK, Chen JX, Chen LH, Lin ZQ, Dai WH, Zhang MQ, Jiang Q, Xiao ZQ, Cheng XX, Zhang XF, You WB, Chen W, Li LQ, Lin WX, Wang YF, Lai FJ, Chen LQ, Huang ZH, Zheng WQ, Wei JQ, Lin ZH. Vonoprazan-amoxicillin dual therapy for Helicobacter pylori eradication in Chinese population: A prospective, multicenter, randomized, two-stage study. World J Gastroenterol. 2024 Jul 21;30(27):3304-3313. doi: 10.3748/wjg.v30.i27.3304.
- Background: PubMed 40908593Song Z, Zuo X, Zhang Z, Wang X, Lin Y, Li Y, Xu X, Huang Y, Wang Q, Shi Y, Zhou L. Ten-Day Versus 14-Day Vonoprazan and Amoxicillin Dual Therapy for the Firstline Eradication of Helicobacter pylori Infection: A Multicenter, Randomized Controlled Trial. Helicobacter. 2025 Sep-Oct;30(5):e70070. doi: 10.1111/hel.70070.
- 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.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Linalarose Glutarate and Bismuth Quadruple Test in people with HELICOBACTER PYLORI INFECTIONS, run by Yongquan Shi at 24 sites 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 9 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongquan Shi, Ph.D (86-029-84771535, von15991351319@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Helicobacter pylori eradication (time frame: 28 days after treatment). 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 NCT07897994, which also lists 2 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 27 Oct 2026.