H. Pylori InfectionNCT06045832
Oral Helicobacter Pylori Eradication
A study testing MAXPOWER Biological Antibacterial Liquid and Water in people with H. Pylori Infection, run by Changhai Hospital at 1 site in China.
Trial summary
Helicobacter pylori (H. pylori) is a serious health threat that infects approximately half of the global population. In addition to colonizing the stomach, H. pylori has been shown to survive in the oral microenvironment and is associated with a variety of oral diseases, gastric eradication failure, and reinfection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- H. Pylori Infection
- What is being tested?
- MAXPOWER Biological Antibacterial Liquid and Water
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 30 Sep 2023
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:Oral H. pylori-positive patients, verified by H. pylori saliva test (HPS),aged 18-70 years visiting the outpatient clinic of Changhai Hospital from March 1, 2023, to August 1, 2023, were enrolled.
Exclusion Criteria: (1) Zollinger-Ellison syndrome, gastric cancer, upper gastrointestinal bleeding, or active peptic ulcer; (2) the coexistence of significant concomitant illnesses, including heart diseases, renal failure, hepatic disease, previous abdominal surgery, lactation or pregnancy; and (3) not willing to participate in the study.
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Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai hospital
Shanghai, Shanghai Municipality, 200433
Yongkang Lai, Dr., +86-18270881495, 409275844@qq.com
About this study
Official title: MAXPOWER Biological Antibacterial Liquid Oral Helicobacter Pylori Eradication Evaluation
Helicobacter pylori (H. pylori) is a serious health threat that infects approximately half of the global population. In addition to colonizing the stomach, H. pylori has been shown to survive in the oral microenvironment and is associated with a variety of oral diseases, gastric eradication failure, and reinfection. Currently, traditional systemic antibiotic therapy has little effect on oral H. pylori, and mouthwashes available on the market for oral H. pylori eradication often contain multiple antibiotics or complex essential ingredients, which can cause unpredictable effects on the human body. Therefore, there is an urgent need for a mouthwash that does not contain antibiotics and is effective against oral H. pylori. This study focuses on the eradication effect of MAXPOWER Biological Antibacterial mouthwash on oral H. pylori in a population.
Read the detailed description
Inclusion criteria: oral H. pylori-positive patients, verified by H. pylori saliva test (HPS),aged 18-70 years visiting the outpatient clinic of Changhai Hospital from March 1, 2023, to August 1, 2023, were enrolled.
Exclusion criteria: (1) Zollinger-Ellison syndrome, gastric cancer, upper gastrointestinal bleeding, or active peptic ulcer; (2) the coexistence of significant concomitant illnesses, including heart diseases, renal failure, hepatic disease, previous abdominal surgery, lactation or pregnancy; and (3) not willing to participate in the study.
Written informed consent was obtained from all patients prior to participation in the study.
- Conditions
- H. Pylori Infection
- Being tested
- MAXPOWER Biological Antibacterial Liquid, Water
- Keywords
- Oral H. pylori, Eradication Evaluation, Antibiotic-free, Mouthwash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAXPOWER Biological Antibacterial LiquidDevice
MAXPOWER Biological Antibacterial Liquid is a mouthwash product self-developed in China, which contains betaine, antibacterial peptide and other antimicrobial substances, which have been proved by experiments to have a good biological safety and at the same time have a killing effect on bacteria. Mouthwash belongs to the category of medical devices, not drugs.
WaterDevice
Water
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | At the beginning of the study, the demographic characteristics of the study participants are recorded in detail, including sex, age, history of smoking, alcohol consumption, presence of bad breath and GI symptoms. The patients who are randomized into control group receive water gargle treatment (Gargle 3 times a day for 2 min each time for 7 days) Then, all patients were retested for oral H. pylori using H. pylori saliva test. Receives: Device: Water |
| MAXPOWER Biological Antibacterial Liquid group | Active comparator | At the beginning of the study, the demographic characteristics of the study participants are recorded in detail, including sex, age, history of smoking, alcohol consumption, presence of bad breath and GI symptoms. The patients who are randomized into MAXPOWER Biological Antibacterial Liquid group receive MAXPOWER Biological Antibacterial Liquid gargle treatment (Gargle 3 times a day for 2 min each time for 7 days) Then, all patients were retested for oral H. pylori using H. pylori saliva test. Receives: Device: MAXPOWER Biological Antibacterial Liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral H. pylori eradication rate
We tested patients for oral H. pylori using H. pylori saliva test (HPS) to .HPS is a lateral flow immunochromatographic test device that uses saliva as testing sample detecting oral H. pylori within few minutes. The principle of HPS is based on monoclonal antibody react with oral urease produced by H. pylori.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Mar 2023
- Primary completion1 Aug 2023
- Study completion30 Sep 2023 (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 H. 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At the beginning of the study, the demographic characteristics of the study participants were recorded in detail, including sex, age, history of smoking, alcohol consumption, presence of bad breath and GI symptoms. After that, a randomization list was generated using SPSS (version 25.0), and the included patients were randomized in a 1:1 ratio according to the randomization table to receive either MAXPOWER Biological Antibacterial Liquid gargle treatment (Gargle 3 times a day for 2 min each time for 7 days) or gargle with water (Gargle 3 times a day for 2 min each time for 7 days). Then, all patients were retested for oral H. pylori.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045832
- Sponsor's protocol ID
- 2023-017
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contact us to obtain the IPD
Publications
Yee JKC. Are the view of Helicobacter pylori colonized in the oral cavity an illusion? Exp Mol Med. 2017 Nov 24;49(11):e397. doi: 10.1038/emm.2017.225.
PubMed 29170474Lai Y, Dong X, Song Y, Zhao J, Du Y, Li Z. Novel MAXPOWER biological antibacterial liquid for eradicating oral Helicobacter pylori. BMC Infect Dis. 2024 May 29;24(1):540. doi: 10.1186/s12879-024-09424-8.
PubMed 38811871
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAXPOWER Biological Antibacterial Liquid Oral Helicobacter Pylori Eradication Evaluation
- ClinicalTrials.gov ID
- NCT06045832
- Acronym / sponsor ID
- 2023-017
- Conditions
- H. Pylori Infection
- Keywords
- Oral H. pylori, Eradication Evaluation, Antibiotic-free, Mouthwash
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 21 Sep 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.
Helicobacter pylori (H. pylori) is a serious health threat that infects approximately half of the global population. In addition to colonizing the stomach, H. pylori has been shown to survive in the oral microenvironment and is associated with a variety of oral diseases, gastric eradication failure, and reinfection. Currently, traditional systemic antibiotic therapy has little effect on oral H. pylori, and mouthwashes available on the market for oral H. pylori eradication often contain multiple antibiotics or complex essential ingredients, which can cause unpredictable effects on the human body. Therefore, there is an urgent need for a mouthwash that does not contain antibiotics and is effective against oral H. pylori. This study focuses on the eradication effect of MAXPOWER Biological Antibacterial mouthwash on oral H. pylori in a population.
Detailed description
Inclusion criteria: oral H. pylori-positive patients, verified by H. pylori saliva test (HPS),aged 18-70 years visiting the outpatient clinic of Changhai Hospital from March 1, 2023, to August 1, 2023, were enrolled.
Exclusion criteria: (1) Zollinger-Ellison syndrome, gastric cancer, upper gastrointestinal bleeding, or active peptic ulcer; (2) the coexistence of significant concomitant illnesses, including heart diseases, renal failure, hepatic disease, previous abdominal surgery, lactation or pregnancy; and (3) not willing to participate in the study.
Written informed consent was obtained from all patients prior to participation in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- At the beginning of the study, the demographic characteristics of the study participants were recorded in detail, including sex, age, history of smoking, alcohol consumption, presence of bad breath and GI symptoms. After that, a randomization list was generated using SPSS (version 25.0), and the included patients were randomized in a 1:1 ratio according to the randomization table to receive either MAXPOWER Biological Antibacterial Liquid gargle treatment (Gargle 3 times a day for 2 min each time for 7 days) or gargle with water (Gargle 3 times a day for 2 min each time for 7 days). Then, all patients were retested for oral H. pylori.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Device: WaterAt the beginning of the study, the demographic characteristics of the study participants are recorded in detail, including sex, age, history of smoking, alcohol consumption, presence of bad breath and GI symptoms. The patients who are randomized into control group receive water gargle treatment (Gargle 3 times a day for 2 min each time for 7 days) Then, all patients were retested for oral H. pylori using H. pylori saliva test. |
| MAXPOWER Biological Antibacterial Liquid group | Active comparator | Device: MAXPOWER Biological Antibacterial LiquidAt the beginning of the study, the demographic characteristics of the study participants are recorded in detail, including sex, age, history of smoking, alcohol consumption, presence of bad breath and GI symptoms. The patients who are randomized into MAXPOWER Biological Antibacterial Liquid group receive MAXPOWER Biological Antibacterial Liquid gargle treatment (Gargle 3 times a day for 2 min each time for 7 days) Then, all patients were retested for oral H. pylori using H. pylori saliva test. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| MAXPOWER Biological Antibacterial LiquidMAXPOWER Biological Antibacterial Liquid is a mouthwash product self-developed in China, which contains betaine, antibacterial peptide and other antimicrobial substances, which have been proved by experiments to have a good biological safety and at the same time have a killing effect on bacteria. Mouthwash belongs to the category of medical devices, not drugs. | Device | MAXPOWER Biological Antibacterial Liquid group |
| WaterWater | Device | Control group |
Primary outcome
Oral H. pylori eradication rate
Time frame: 7 days
We tested patients for oral H. pylori using H. pylori saliva test (HPS) to .HPS is a lateral flow immunochromatographic test device that uses saliva as testing sample detecting oral H. pylori within few minutes. The principle of HPS is based on monoclonal antibody react with oral urease produced by H. pylori.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 29170474Yee JKC. Are the view of Helicobacter pylori colonized in the oral cavity an illusion? Exp Mol Med. 2017 Nov 24;49(11):e397. doi: 10.1038/emm.2017.225.
- Derived from this study: PubMed 38811871Lai Y, Dong X, Song Y, Zhao J, Du Y, Li Z. Novel MAXPOWER biological antibacterial liquid for eradicating oral Helicobacter pylori. BMC Infect Dis. 2024 May 29;24(1):540. doi: 10.1186/s12879-024-09424-8.
- Individual participant dataSharing planned: No. Contact us to obtain the IPD
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAXPOWER Biological Antibacterial Liquid and Water in people with H. Pylori Infection, run by Changhai 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?
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 21 Sep 2023. 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.
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 Yongkang Lai, Dr. (+86-18270881495, 4090275844@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral H. pylori eradication rate (time frame: 7 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 NCT06045832, 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 21 Sep 2023.