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

Primary Purpose

Helicobacter Pylori Infection

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esomeprazole
Amoxicillin
Bismuth Potassium Citrate
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Helicobacter Pylori Infection focused on measuring helicobacter pylori, saliva microbiota

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Renji Hospital, School of Medicine, Shanghai Jiao Tong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bismuth Plus triple Therapy

Arm Description

Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 2, 2018
Last Updated
November 2, 2018
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03730766
Brief Title
Analysis of the Impact of Helicobacter Pylori on Salivary Microbiome in Adults
Official Title
Analysis of the Impact of Helicobacter Pylori Infection and Eradication on Salivary Microbiome in Adults by 16S Pyrosequencing
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
November 15, 2018 (Anticipated)
Study Completion Date
November 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
helicobacter pylori, saliva microbiota

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bismuth Plus triple Therapy
Arm Type
Experimental
Arm Description
Esomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Proton pump inhibitor
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Other Intervention Name(s)
Metronidazole
Intervention Description
Antibiotics for H. pylori eradication
Intervention Type
Drug
Intervention Name(s)
Bismuth Potassium Citrate
Intervention Description
Gastric mucosal protective drug with anti-H. pylori effect
Primary Outcome Measure Information:
Title
Change of saliva microbiota after eradication
Description
Two months after completion of therapy, saliva microbiota was assessed by 16S rDNA Pyrosequencing.
Time Frame
Two months after completion of therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yingjie Ji, M.D.
Phone
86+15800575527
Email
jiyingjie39@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Lu, M.D., Ph.D.
Organizational Affiliation
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yingjie Ji, M.D
Phone
86+15800575527
Email
jiyingjie39@outlook.com
First Name & Middle Initial & Last Name & Degree
Hong Lu, M.D., Ph.D
First Name & Middle Initial & Last Name & Degree
Yingjie Ji, M.D

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32197614
Citation
Ji Y, Liang X, Lu H. Analysis of by high-throughput sequencing: Helicobacter pylori infection and salivary microbiome. BMC Oral Health. 2020 Mar 20;20(1):84. doi: 10.1186/s12903-020-01070-1.
Results Reference
derived

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

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