Clinical trial NCT06045832: Oral Helicobacter Pylori Eradication
Official title: MAXPOWER Biological Antibacterial Liquid Oral Helicobacter Pylori Eradication Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: H. Pylori Infection
Keywords: Oral H. pylori
Eradication Evaluation
Antibiotic-free
Mouthwash
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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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Primary outcomes:
measure: Oral H. pylori eradication rate
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
state: Shanghai
Study officials:
References:
citation: 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.