Analysis of the Impact of Helicobacter Pylori on Salivary Microbiome in Adults

Phase 4

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Esomeprazole; Drug: Amoxicillin; Drug: Bismuth Potassium Citrate

• Registration Number: NCT03730766
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-02
• Study First Submitted QC: 2018-11-02
• Last Update Submitted: 2018-11-02
• Study First Posted: 2018-11-05
• Last Update Posted: 2018-11-05
• Primary Completion: 2018-11-15
• Study Completion: 2018-11-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bismuth Plus triple Therapy	Bismuth Potassium Citrate	Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Bismuth Plus triple Therapy	Esomeprazole	Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Bismuth Plus triple Therapy	Amoxicillin	Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Primary Outcome Measures

Name	Time	Method
Change of saliva microbiota after eradication	Two months after completion of therapy.	Two months after completion of therapy, saliva microbiota was assessed by 16S rDNA Pyrosequencing.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China