Analysis of the Impact of Helicobacter Pylori on Salivary Microbiome in Adults
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2018
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 2, 2018
CompletedFirst Posted
Study publicly available on registry
November 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2018
CompletedNovember 5, 2018
November 1, 2018
4 months
November 2, 2018
November 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
Bismuth Plus triple Therapy
EXPERIMENTALEsomeprazole 20mg bid, Bismuth Potassium Citrate 600mg bid, Amoxicillin 1.0g tid and Metronidazole 0.4g tid for 14 days
Interventions
Antibiotics for H. pylori eradication
Gastric mucosal protective drug with anti-H. pylori effect
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Less than 18 years old
- With previous gastric surgery
- Major systemic diseases
- Pregnancy or lactation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127, China
Related Publications (1)
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.
PMID: 32197614DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Lu, M.D., Ph.D.
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
Study Record Dates
First Submitted
November 2, 2018
First Posted
November 5, 2018
Study Start
August 1, 2018
Primary Completion
November 15, 2018
Study Completion
November 20, 2018
Last Updated
November 5, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share