Oral Helicobacter Pylori Eradication
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ClinicalTrials.gov Identifier: NCT06045832 |
Recruitment Status :
Recruiting
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
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Condition or disease | Intervention/treatment | Phase |
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H. Pylori Infection | Device: MAXPOWER Biological Antibacterial Liquid Device: Water | Not Applicable |
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 (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 |
Arm | Intervention/treatment |
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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.
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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.
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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. |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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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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
Contact: Yongkang Lai, Dr. | +86-18270881495 | 4090275844@qq.com |
China, Shanghai | |
Changhai hospital | Recruiting |
Shanghai, Shanghai, China, 200433 | |
Contact: Yongkang Lai, Dr. +86-18270881495 409275844@qq.com |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Oral H. pylori Eradication Evaluation Antibiotic-free Mouthwash |
Anti-Bacterial Agents Anti-Infective Agents |