Oral Helicobacter Pylori Eradication

Last updated: September 13, 2023
Sponsor: Changhai Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-ulcer Dyspepsia (Nud)

Treatment

Water

MAXPOWER Biological Antibacterial Liquid

Clinical Study ID

NCT06045832
2023-017
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria: (1) Zollinger-Ellison syndrome, gastric cancer, upper gastrointestinalbleeding, 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.

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Water
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
September 30, 2023

Study 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.

Connect with a study center

  • Changhai hospital

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

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