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

Helicobacter Pylori Infection Clinical Trial

Official title:

Analysis of the Impact of Helicobacter Pylori Infection and Eradication on Salivary Microbiome in Adults by 16S Pyrosequencing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03730766
• Other study ID #: rjyy20180801
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2018
• Est. completion date: November 20, 2018

Study information

• Verified date: November 2018
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Yingjie Ji, M.D.
• Phone: 86+15800575527
• Email: jiyingjie39[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 20, 2018
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• Esomeprazole
Proton pump inhibitor
• Amoxicillin
Antibiotics for H. pylori eradication
• Bismuth Potassium Citrate
Gastric mucosal protective drug with anti-H. pylori effect

Locations

Country	Name	City	State
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of saliva microbiota after eradication	Two months after completion of therapy, saliva microbiota was assessed by 16S rDNA Pyrosequencing.	Two months after completion of therapy.