Oral Helicobacter Pylori Eradication

September 13, 2023 updated by: Changhai Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

August 1, 2023

Study Completion (Estimated)

September 30, 2023

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 13, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Contact us to obtain the IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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