Analysis of the Impact of Helicobacter Pylori Infection and Eradication on Salivary Microbiome in Adults by 16S Pyrosequencing
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change of saliva microbiota after eradication
Study Overview
Brief Summary
Helicobacter pylori (H. pylori), a bacteria transmitted from human to human through upper digestive tract as well as fecal-oral transmission, had infected more than half of people around the world. However, the quantity of H. pylori in oral cavity and its influence on oral microbiota remains to be unclear. The aim of the present study was to examine the effects of H. pylori infection as well as its eradication on oral microbiota.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participants with non-ulcer functional dyspepsia or peptic ulcer disease
- •Ability and willingness to participate in the study and to sign and give informed consent
- •Received both endoscopy and 13C urea breath test (13C-UBT) before enrolled
Exclusion Criteria
- •Less than 18 years old
- •With previous gastric surgery
- •Major systemic diseases
- •Pregnancy or lactation
- •Allergy to any of the study drugs Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion
- •The use of antibiotics or PPI within 2 months before the study
- •The presence of dental carious or any untreated cavitated carious lesions and oral abscesses
Arms & Interventions
Bismuth Plus triple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Intervention: Esomeprazole (Drug)
Bismuth Plus triple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Intervention: Amoxicillin (Drug)
Bismuth Plus triple Therapy
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Intervention: Bismuth Potassium Citrate (Drug)
Outcomes
Primary Outcomes
Change of saliva microbiota after eradication
Time Frame: Two months after completion of therapy.
Two months after completion of therapy, saliva microbiota was assessed by 16S rDNA Pyrosequencing.
Secondary Outcomes
No secondary outcomes reported
Investigators
Hong Lu, MD
Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
Shanghai Jiao Tong University School of Medicine