Helicobacter Pylori InfectionPhase 4NCT05749081
Helicobacter Pylori and Lacidophilin Tablets in Combination With Vonorazan Dual Therapy
A Phase 4 study testing Lacidophilin tablets in combination with vonorazan dual therapy in people with Helicobacter Pylori Infection, run by The First Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
Our previous study included 119 Helicobacter pylori(H. pylori)-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either b.i.d. or t.i.d plus vonoprazan 20 mg b.i.d for 7 or 10 days. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Lacidophilin tablets in combination with vonorazan dual therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 324 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2023to Jul 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
- Consecutive H. pylori-infected subjects ages from 18 to 70 without eradication history
Who cannot join
- allergy to amoxicillin,vonoprazan or lacidophilin tablets;
- acute upper gastrointestinal bleeding, gastric cancer or other tumors, Zollinger-Ellison syndrome, history of gastric surgery;
- gastroscopy report showing or past medical history of significant esophagogastric disease, including gastric cancer, peptic ulcer, esophagitis, esophageal erosion.
- serious illness including neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrinological or hematological disorders;
- pregnancy or breast feeding;
- proton pump inhibitors, antibiotics and probiotics use within one month;
- not willing to participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital, Jiangxi Medical College, NanChang University
Nanchang, Jiangxi
About this study
Official title: Lacidophilin Tablets in Combination With Vonorazan and Amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection: a Prospective, Multi-centers, Superiority, Double-blind, Randomized Clinical Study
Our previous study included 119 Helicobacter pylori(H. pylori)-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either b.i.d. or t.i.d plus vonoprazan 20 mg b.i.d for 7 or 10 days. Neither 7-or 10-day VA dual therapy with either b.i.d. or t.i.d. amoxicillin achieved satisfied efficacy (i.e., <90%) when given as first-line treatment for H. pylori infection. Lacidophilin tablets have been reported to increase the eradication rate of H. pylori while reducing the incidence of adverse effects.This study evaluated the efficacy and safety of lacidophilin tablets in combination with amoxicillin-vonoprazan dual therapy for 10 days as first-line treatment for H. pylori in China.
Read the detailed description
This study was designed as a prospective, multi-centers, double-blind, randomized superiority clinical study and was conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.
Consecutive H. pylori-infected subjects ages from 18 to 70 without eradication history were recruited . H. pylori infection was confirmed by immunohistochemistry or urea breath test.
The H. pylori-infected subjects were randomly assigned to receive lacidophilin tablets or placebo in combination with amoxicillin-vonoprazan dual therapy for in a 1:1 allocation ratio, a randomization list was generated using Statistical Product Service Solutions (version 25.0).
The therapy consisted of 2400mg lacidophilin tablets or placebo three times daily, 1000 mg amoxicillin capsules three times daily and 20mg vonoprazan fumarate tablets twice daily for 10 days. The shape, taste, packaging, storage method and administration method of placebo are the same as lacidophilin tablets. Participants and investigators were blinded to the allocated treatment group.
At the start, the detailed demographics and characteristics of the subjects included in this study were recorded, including sex, age, nationality, height, weight, education status, dwelling area, history of smoking and alcohol, concomitant diseases and medication history. In addition, physical examinations and assessment of vital signs were performed. Gastric antrum and body biopsy of the included subjects were obtained during the endoscopy, which were followed by culture and susceptible test of antibiotics. Fecal sample was collected before eradication.
During (or after) treatment-emergent adverse events (TEAEs) and concomitant medication were recorded throughout the study, including bloating, nausea, vomiting, abdominal pain, diarrhea, constipation, skin rash, headache, hunger sensation and others. All TEAEs were divided into mild, moderate and severe, TEAEs leading to study drug discontinuation were also recorded. Fecal sample was collected after eradication.
The confirmation of H. pylori status was evaluated by 13C-urea breath test 4-8 weeks after treatment. H. pylori status was considered as negative or positive according to the instructions of the manufacturer. Oral and fecal sample was collected at the timepoint of recheck.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Lacidophilin tablets in combination with vonorazan dual therapy, Placebo in combination with vonorazan dual therapy
- Keywords
- Helicobacter pylori, vonoprazan, Lacidophilin Tablets, amoxicillin, eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacidophilin tablets in combination with vonorazan dual therapyDrug
2400mg lacidophilin tablets three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days
Placebo in combination with vonorazan dual therapyDrug
2400mg placebo three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| Lacidophilin tablets group | Experimental | 2400mg lacidophilin tablets three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days Receives: Drug: Lacidophilin tablets in combination with vonorazan dual therapy |
| Placebo group | Placebo comparator | 2400mg placebo three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days Receives: Drug: Placebo in combination with vonorazan dual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Treatment
The confirmation of H. pylori status was evaluated by urea breath test
Measured: 4-8 weeks after treatment
Secondary outcomes (4)
Incidence of Treatment-Emergent Adverse Events
the frequency and severity of treatment-emergent adverse events
Measured: 1 day after eradication
Compliance of Participants
good compliance was defined as achieving ≥80% of drugs included in the regimes and bad compliance was defined as achieving <80% drugs
Measured: 1 day after eradication
Resistance of Antibiotics
An E-test was used to determine the minimum inhibitory concentrations (MIC) of Amoxicillin (AMO), Metronidazole (MET), Clarithromycin (CLA), Levofloxacin (LEV) and tetracycline (TET). The Kirby-Bauer disc diffusion method (Oxoid) was used to determine the inhibition zone for Furazolidone (FUR). A strain was considered resistant if the MIC>1 mg/mL for AMO, ≥1 mg/mL for CLA, >2 mg/mL for TET, >4 mg/mL for MET, MIC >1 mg/mL for LEV and if the inhibition zone was <7 mm for FUR. H. pylori strain ATCC 43504 was included as an antibiotic susceptibility testing qualitycontrol. All antibiotic susceptibility tests were conducted at the Institute of Gastroenterology and Hepatology, First Affiliated Hospital of Nanchang University.
Measured: before the eradication
Alteration of Gut Microbiota
The oral and fecal samples were collected before eradication,1 day after eradication and confirmation（6-8 weeks after treatment）. Bioinformatics of gut microbiome were performed using QIIME2 with slight modification and R packages. Briefly, Non-singleton ASVs were aligned and used to construct a phylogeny with fasttree2. Alpha-diversity metrics were calculated using the ASV table in QIIME2 and visualized as box plots. ASV-level ranked abundance curves were generated to compare the richness and evenness of ASVs among samples. Beta diversity analysis was conducted to explore the structural variation of microbial communities across samples using Bray-Curtis metrics and visualized via principal coordinate analysis (PCoA). The significance of microbiota structure differences among groups was assessed by Permanova using QIIME2. Microbial functions were predicted by PICRUSt2 upon KEGG (https://www.kegg.jp/) databases.
Measured: before eradication，1 day after eradication and confirmation（4-8 weeks after treatment）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start13 May 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingyu Luo, The First Affiliated Hospital of Nanchang University
- Investigators
- Cong He, phD, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749081
- Sponsor's protocol ID
- Hp therapy of FirstNanchangU
- Status last verified
- Jun 2024
- First submitted
- 18 Feb 2023
- Last updated
- 18 Jun 2024
- Results posted
- 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 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lacidophilin Tablets in Combination With Vonorazan and Amoxicillin Dual Therapy for Eradicating Helicobacter Pylori Infection: a Prospective, Multi-centers, Superiority, Double-blind, Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05749081
- Acronym / sponsor ID
- Hp therapy of FirstNanchangU
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori, vonoprazan, Lacidophilin Tablets, amoxicillin, eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 13 May 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 1 Mar 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.
Our previous study included 119 Helicobacter pylori(H. pylori)-infected Chinese patients without previous eradication history who were randomized to low-or high-dose amoxicillin-vonoprazan regimens consisting of amoxicillin 1 gram either b.i.d. or t.i.d plus vonoprazan 20 mg b.i.d for 7 or 10 days. Neither 7-or 10-day VA dual therapy with either b.i.d. or t.i.d. amoxicillin achieved satisfied efficacy (i.e., <90%) when given as first-line treatment for H. pylori infection. Lacidophilin tablets have been reported to increase the eradication rate of H. pylori while reducing the incidence of adverse effects.This study evaluated the efficacy and safety of lacidophilin tablets in combination with amoxicillin-vonoprazan dual therapy for 10 days as first-line treatment for H. pylori in China.
Detailed description
This study was designed as a prospective, multi-centers, double-blind, randomized superiority clinical study and was conducted in accordance with the Declaration of Helsinki and the guidelines of the Consolidated Standards of Reporting Trials.
Consecutive H. pylori-infected subjects ages from 18 to 70 without eradication history were recruited . H. pylori infection was confirmed by immunohistochemistry or urea breath test.
The H. pylori-infected subjects were randomly assigned to receive lacidophilin tablets or placebo in combination with amoxicillin-vonoprazan dual therapy for in a 1:1 allocation ratio, a randomization list was generated using Statistical Product Service Solutions (version 25.0).
The therapy consisted of 2400mg lacidophilin tablets or placebo three times daily, 1000 mg amoxicillin capsules three times daily and 20mg vonoprazan fumarate tablets twice daily for 10 days. The shape, taste, packaging, storage method and administration method of placebo are the same as lacidophilin tablets. Participants and investigators were blinded to the allocated treatment group.
At the start, the detailed demographics and characteristics of the subjects included in this study were recorded, including sex, age, nationality, height, weight, education status, dwelling area, history of smoking and alcohol, concomitant diseases and medication history. In addition, physical examinations and assessment of vital signs were performed. Gastric antrum and body biopsy of the included subjects were obtained during the endoscopy, which were followed by culture and susceptible test of antibiotics. Fecal sample was collected before eradication.
During (or after) treatment-emergent adverse events (TEAEs) and concomitant medication were recorded throughout the study, including bloating, nausea, vomiting, abdominal pain, diarrhea, constipation, skin rash, headache, hunger sensation and others. All TEAEs were divided into mild, moderate and severe, TEAEs leading to study drug discontinuation were also recorded. Fecal sample was collected after eradication.
The confirmation of H. pylori status was evaluated by 13C-urea breath test 4-8 weeks after treatment. H. pylori status was considered as negative or positive according to the instructions of the manufacturer. Oral and fecal sample was collected at the timepoint of recheck.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lacidophilin tablets group | Experimental | Drug: Lacidophilin tablets in combination with vonorazan dual therapy2400mg lacidophilin tablets three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days |
| Placebo group | Placebo comparator | Drug: Placebo in combination with vonorazan dual therapy2400mg placebo three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive H. pylori-infected subjects ages from 18 to 70 without eradication history
Key exclusion criteria (7 listed)
- allergy to amoxicillin,vonoprazan or lacidophilin tablets;
- acute upper gastrointestinal bleeding, gastric cancer or other tumors, Zollinger-Ellison syndrome, history of gastric surgery;
- gastroscopy report showing or past medical history of significant esophagogastric disease, including gastric cancer, peptic ulcer, esophagitis, esophageal erosion.
- serious illness including neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urological, endocrinological or hematological disorders;
- pregnancy or breast feeding;
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 |
|---|---|---|
| Lacidophilin tablets in combination with vonorazan dual therapy2400mg lacidophilin tablets three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days | Drug | Lacidophilin tablets group |
| Placebo in combination with vonorazan dual therapy2400mg placebo three times daily,1000mg amoxicillin capsules three times daily and 20mg vonoprazan Fumarate Tablets twice daily for 10 days | Drug | Placebo group |
Primary outcome
Efficacy of Treatment
Time frame: 4-8 weeks after treatment
The confirmation of H. pylori status was evaluated by urea breath test
4 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 1 day after eradication
Compliance of Participants
Time frame: 1 day after eradication
Resistance of Antibiotics
Time frame: before the eradication
Alteration of Gut Microbiota
Time frame: before eradication，1 day after eradication and confirmation（4-8 weeks after treatment）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Helicobacter Pylori Infection
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
Not yet recruitingPhase 2
Vonoprazan-Amoxicillin Dual Therapy for Helicobacter Pylori Infection in United States Adolescents
Helicobacter Pylori Infection
Active, not recruiting
Efficacy and Safety of Second-Line Helicobacter Pylori Eradication
HELICOBACTER PYLORI INFECTIONS
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.
Cong He, phD principal investigator
The First Affiliated Hospital of Nanchang University
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 Lacidophilin tablets in combination with vonorazan dual therapy in people with Helicobacter Pylori Infection, run by The First Affiliated Hospital of Nanchang University 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 18 Jun 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Efficacy of Treatment (time frame: 4-8 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 18 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.