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

S

Shanghai Jiao Tong University School of Medicine

Status and phase

Unknown
Phase 4

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Esomeprazole
Drug: Bismuth Potassium Citrate
Drug: Amoxicillin

Study type

Interventional

Funder types

Other

Identifiers

NCT03730766
rjyy20180801

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Bismuth Plus triple Therapy
Experimental group
Description:
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Treatment:
Drug: Bismuth Potassium Citrate
Drug: Amoxicillin
Drug: Esomeprazole

Trial contacts and locations

1

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Central trial contact

Yingjie Ji, M.D.

Data sourced from clinicaltrials.gov

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