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Oral Helicobacter Pylori Eradication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06045832
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Information provided by (Responsible Party):
Changhai Hospital

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
H. Pylori Infection Device: MAXPOWER Biological Antibacterial Liquid Device: Water Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Treatment
Official Title: MAXPOWER Biological Antibacterial Liquid Oral Helicobacter Pylori Eradication Evaluation
Actual Study Start Date : March 1, 2023
Actual Primary Completion Date : August 1, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control group
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.
 Device: Water
Water
Active Comparator: MAXPOWER Biological Antibacterial Liquid group
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.
 Device: MAXPOWER Biological Antibacterial Liquid
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06045832


Contacts
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Contact: Yongkang Lai, Dr. +86-18270881495 4090275844@qq.com

Locations
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China, Shanghai
Changhai hospital Recruiting
Shanghai, Shanghai, China, 200433
Contact: Yongkang Lai, Dr.    +86-18270881495    409275844@qq.com   
Sponsors and Collaborators
Changhai Hospital
More Information
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Publications:

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Responsible Party: Changhai Hospital
ClinicalTrials.gov Identifier: NCT06045832    
Other Study ID Numbers: 2023-017
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Contact us to obtain the IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Changhai Hospital:
Oral H. pylori
Eradication Evaluation
Antibiotic-free
Mouthwash
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents